Arthrex® AR-9145-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867057739), received between Apr 18, 2018 and Aug 11, 2025 — classified as 17 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN ANATOMICAL SHOULDER PROSTHESIS WITH UNIVERSAL GLENOID THE BASE PLATE COULD NOT BE IMPLANTED COMPLETELY. THE SURGEON REPLACED THE PERIPHER AND CENTRAL SCREW WITHOUT SUCCESS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6) 31-JUL-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED BASE PLATE WAS INITIALLY IMPLANTED FOUR YEARS AGO. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY 3 MONTHS AGO WHERE THE INLAY AR-9121-02 WAS REVISED. THE PATIENT CONTINUED TO HAVE ISSUES AND UNDERWENT THE SECOND REVISION ON (B)(6) 2025. DURING THE REVISION THE INITIALLY REPORTED EVENT HAS BEEN IDENTIFIED AND THE SURGEON REVISED THE BASE PLATE AND 3 SCREWS.

  Patient problems: Failure of Implant

  MAUDE report 22771541 ↗
• MalfunctionJan 8, 2025Positioning Failure; Positioning Failure

  ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9145-36 PERIPHERAL LOCKING SCREW WOULD NOT LOCK. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WHEN THE SCREW WOULD NOT LOCK INTO THE PLATE. THE SCREW WAS REMOVED AND REPLACED WITH AN AR-9145-30 WHICH WORKED ACCORDINGLY. THERE WAS NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21103419 ↗
• MalfunctionJan 8, 2025Positioning Failure; Positioning Failure

  ON 12/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-9145-36 PERIPHERAL LOCKING SCREW WOULD NOT LOCK. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WHEN THE SCREWS WOULD NOT LOCK INTO THE PLATE CORRECTLY. THE SCREWS WERE NOT REMOVED DUE TO CONCERN ABOUT THE PATIENT HAVING HARD BONE AND THE HEAD OF THE SCREW BREAKING OFF. THE CASE WAS COMPLETED WITH NO ISSUES AND NO IMPACT ON THE PATIENT. THERE WAS NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21103387 ↗
• MalfunctionJan 8, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-9145-36 PERIPHERAL LOCKING SCREW WOULD NOT LOCK. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6)2024 WHEN THE SCREWS WOULD NOT LOCK INTO THE PLATE CORRECTLY. THE SCREWS WERE NOT REMOVED DUE TO CONCERN ABOUT THE PATIENT HAVING HARD BONE AND THE HEAD OF THE SCREW BREAKING OFF. THE CASE WAS COMPLETED WITH NO ISSUES AND NO IMPACT ON THE PATIENT. THERE WAS NO DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21103127 ↗
• MalfunctionDec 13, 2024Positioning Failure; Positioning Failure

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-9145-36 ARTHREX UNIVERSAL GLENOID¿ PERIPHERAL LOCKING SCREWS WOULDN'T LOCK. THIS OCCURRED DURING A REVERS TOTAL SHOULDER ON (B)(6)2024 WHEN THEY WERE PUTTING THEM IN, THEY WOULDN¿T LOCK. THE SCREWS WERE REMOVED AND THE CASE CONTINUED USING OTHER AR-9145-36 ARTHREX UNIVERSAL GLENOID¿ - PERIPHERAL LOCKING SCREWS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926192 ↗
• MalfunctionDec 12, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-9145-36 ARTHREX UNIVERSAL GLENOID¿ PERIPHERAL LOCKING SCREWS WOULDN'T LOCK. THIS OCCURRED DURING A REVERS TOTAL SHOULDER ON (B)(6) 2024 WHEN THEY WERE PUTTING THEM IN, THEY WOULDN¿T LOCK. THE SCREWS WERE REMOVED AND THE CASE CONTINUED USING OTHER AR-9145-36 ARTHREX UNIVERSAL GLENOID¿ - PERIPHERAL LOCKING SCREWS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20921097 ↗
• MalfunctionOct 28, 2024Positioning Failure; Positioning Failure

  ON 10/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 2 OF AN AR-9145-36 ARTHREX UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW 36 MM HAD AN ISSUE DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2024. WHEN THE SURGEON WAS TRYING TO LOCK THE FIRST SCREW INTO AN AR-9120-01PC REVERS GLENOID POROUS COAT BASEPLATE, S, HE FELT THE SCREW WAS NOT LOCKING DOWN CORRECTLY. HE BACKED OUT THE SCREW, AS THIS HAD OCCURRED IN A PREVIOUS CASE WHICH HAD BEEN PREVIOUSLY REPORTED AND DISCARDED THE DEVICE. HE THEN USED A SECOND AR-9145-36 ARTHREX UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW 36 MM WITH THE SAME BATCH NUMBER, WHICH HE FELT WAS ALSO NOT LOCKING DOWN CORRECTLY. HOWEVER, IT WAS DOWN ENOUGH AND AFFIXED CORRECTLY TO LEAVE IT INSIDE THE PATIENT. THE SURGEON FELT THE TWO SCREWS WERE NOT BITING CORRECTLY INTO THE BASEPLATE AND WANTED TO REPORT THE COMPLAINT. THERE WAS NO ISSUE OBSERVED WITH THE BASE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544066 ↗
• MalfunctionOct 28, 2024Positioning Failure; Positioning Failure

  ON 10/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT QTY. 2 OF AN AR-9145-36 ARTHREX UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW 36 MM HAD AN ISSUE DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2024. WHEN THE SURGEON WAS TRYING TO LOCK THE FIRST SCREW INTO AN AR-9120-01PC REVERS GLENOID POROUS COAT BASEPLATE, S, HE FELT THE SCREW WAS NOT LOCKING DOWN CORRECTLY. HE BACKED OUT THE SCREW, AS THIS HAD OCCURRED IN A PREVIOUS CASE WHICH HAD BEEN PREVIOUSLY REPORTED, AND DISCARDED THE DEVICE. HE THEN USED A SECOND AR-9145-36 ARTHREX UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW 36 MM WITH THE SAME BATCH NUMBER, WHICH HE FELT WAS ALSO NOT LOCKING DOWN CORRECTLY. HOWEVER, IT WAS DOWN ENOUGH AND AFFIXED CORRECTLY TO LEAVE IT INSIDE THE PATIENT. THE SURGEON FELT THE TWO SCREWS WERE NOT BITING CORRECTLY INTO THE BASEPLATE AND WANTED TO REPORT THE COMPLAINT. THERE WAS NO ISSUE OBSERVED WITH THE BASE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20543928 ↗
• MalfunctionOct 28, 2024Break; Positioning Failure; Break; Positioning Failure

  ON 10/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9145-36 ARTHREX UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW 36 MM HAD AN ISSUE DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2024. WHEN THE SURGEON WAS TRYING TO LOCK THE SCREW INTO AN AR-9120-01PC REVERS GLENOID POROUS COAT BASEPLATE, S, HE FELT THE SCREW WAS NOT LOCKING DOWN CORRECTLY. HE BACKED OUT THE SCREW, RE-SCREWED IT, AND FELT IT WAS DOWN ENOUGH AND AFFIXED CORRECTLY TO USE IT. THE SCREW REMAINED INSIDE THE PATIENT, AND NO PICTURES WERE TAKEN. THE SURGEON FELT THE SCREW WAS NOT BITING CORRECTLY INTO THE BASEPLATE AND WANTED TO REPORT THE COMPLAINT. THERE WAS NO ISSUE OBSERVED WITH THE BASE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20543742 ↗
• InjuryJul 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A METALLOSIS. THE IMPLANT WAS IMPLANTED FOUR YEARS AGO WITH BONE GRAFT AUGMENTATION.. NO FURTHER INFORMATION WAS PROVIDED. UPDATE DW 12-JUL-2024: FURTHER INFORMATION WERE PROVIDED THAT DURING AN INITIAL SURGERY ON (B)(6) 2020 THE FOLLOWING DEVICES WERE IMPLANTED DUE TO AN OMARTHROSIS WITH B2 GLENOID SITUATION WITH A RETRO OF JUST UNDER 30 DEGREES . AR-9120-03, AR-9165-25NL, AR-9145-36, AR-9121-03, AR-9300-45CPC, AR-9301-04. ON (B)(6) 2024 THE REVISION SURGERY WAS PERFORMED. AS PART OF THE REVISION THE ECLIPSE AND UNIVERSAL GLENOID WERE ALL REMOVED DUE TO A SEVERE METALLOSIS. THE SURGEON DECIDED TO FIRST BUILD UP THE GLENOID WITH ALLOGRAFT IN A TWO-SIDED PROCEDURE AND TO INSERT A CEMENT SPACER ON THE HUMERUS SIDE. IN THE SECOND STEP - A UNIVERS REVERSE WILL BE INSERTED IN AUTUMN WITH PLANNING.

  Patient problems: Metal Related Pathology

  MAUDE report 19837700 ↗
• InjuryOct 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A LOOSENING OF THE ECLIPSE PROSTHESIS LED TO REVISION TO UNIVERS REVERS. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED: ECLIPSE HEAD, ECLIPSE TRUNION, ECLIPSE CAGE SCREW AND UNIVERSAL GLENOID INLAY. THE UNIVERSAL GLENOID HAD A GOOD ANCHORAGE, SO THE PE WAS REMOVED AND A GLENOSPHERE WAS INSTALLED. ON THE HUMERAL SIDE AN ECLIPSE REMOVED AND UNIVERS REVERS INSTALLED. NO FURTHER INFORMATION RECEIVED. UPDATE ON 03-OCT-2023: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017 AND THE FOLLOWING DEVICES WERE IMPLANTED: AR-9145-30 LOT: 160058310. AR-9165-15 LOT: 160064010. AR-9120-01 LOT: 160061912. AR-9145-36 LOT: 160058410 AR-9121-01 LOT: 160101410 AR-9300-41CPC.

  Patient problems: Failure of Implant

  MAUDE report 17995033 ↗
• InjuryOct 20, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2023 THE PATIENT DEVELOPED A SEVERE INFECTION WHICH AFFECTED THE PATIENT FOR 6 MONTHS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO REMOVE THE INVOLVED IMPLANTS. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 17977151 ↗
• InjuryJun 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A PATIENT THAT AN ARTHREX ECLIPSE STEMLESS HUMERAL IMPLANT AND CONVERTIBLE UNIVERSAL GLENOID PRODUCTS WERE IMPLANTED DURING A SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2023. THE PATIENT IS EXPERIENCING A POSSIBLE UNSPECIFIED REACTION. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17199165 ↗
• MalfunctionMay 18, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE HEAD OF AN AR-9145-36 PERIPHERAL LOCKING SCREW BROKE DURING INSERTION. THE SURGEON DECIDED TO LEAVE THE BODY IMPLANTED AS IT WAS NOT PROUD OR CAUSING ANY EFFECT ON THE CASE OR TO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 16954774 ↗
• InjuryApr 28, 2023Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO AN ASEPTIC LOOSENING OF THE BASEPLATE. IT WAS FURTHER REPORTED THAT A CAUDAL SCREW BREAKAGE AND A METALLOSIS OCCURRED. A RESECTION ARTHROPLASTY WAS PERFORMED TO RESOLVE THE ISSUE. (B)(6) 2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE BROKEN SCREW HAD THE PART NUMBER AR-9145-36.

  Patient problems: Failure of Implant

  MAUDE report 16838659 ↗
• InjuryMay 9, 2022Degraded

  IT WAS REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF A RIGHT SHOULDER TOTAL ENDO-PROSTHESIS ECLIPSE ON (B)(6) 2016, POLYETHYLENE DEGRADATION WAS IDENTIFIED POST-OPERATIVELY. THIS RESULTED IN A BONE DEFECT WHICH LED TO A REVISION SURGERY TO CHANGE THE IMPLANT TO AN INVERSE PROSTHESIS.

  Patient problems: Failure of Implant

  MAUDE report 14336853 ↗
• MalfunctionMar 14, 2022Break

  IT WAS REPORTED THAT DURING AN UNIVERSAL GLENOID / ECLIPSE PROSTHESIS SURGERY THE DISTAL SCREW ON THE UNIVERSAL GLENOID BROKE OFF CLOSE TO THE HEAD AFTER IT WAS INSERTED AROUND 25 MM. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13758988 ↗
• InjuryNov 23, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE FOLLOWING ISSUES OCCURRED WITH TWO ARTHREX INSTRUMENTS: INSTRUMENT 1: THE MEDIUM T-15 DRIVER (AR-9545-T15-02 #8001928) HAS BEEN COMPROMISED. WHEN TRYING TO EXTRACT THE CENTRAL SCREW FROM A UNIVERSAL GLENOID, THE TIP OF THE DRIVER BECAME TWISTED AND A SMALL PIECE BROKE OFF INTO THE HEAD OF THE CENTRAL SCREW. THERE WAS A 5 MINUTE DELAY IN SURGERY AS THE SCREW HEAD COULD NO LONGER BE ACCESSED. THE SURGEON USED OSTEOTOMES AROUND THE PERIPHERY OF THE BASEPLATE TO EVENTUALLY EXTRACT THE BASEPLATE AND CENTRAL SCREW AS ONE PIECE. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED, BUT THE SMALLER PIECE WAS LODGED INTO THE CENTRAL SCREW IMPLANT WHICH WAS NOT AVAILABLE FOR RETURN. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. INSTRUMENT 2: THE TRINITY BASEPLATE IMPACTOR (AR-9165CDG #(10)051917) HAS BEEN COMPROMISED. THE SURGEON ENGAGED THE ALREADY IMPLANTED BASEPLATE WITH THE IMPACTOR SO THAT IMPACTION MIGHT DISRUPT THE BONY BOND WITH THE BASEPLATE. AFTER

  Patient problems: Foreign Body In Patient; Pain; Unspecified Infection

  MAUDE report 10884277 ↗
• InjurySep 2, 2020Signal Artifact/Noise; Corroded

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL REVISION SURGERY ON (B)(6) 2018 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: AR-9120-01 (LOT 170115215), AR-9145-36 (LOT 170037012), AR-9145-30 (LOT 170057712), AR-9504S-04 (LOT 170091414), AR-9555-09 (LOT 2501367202), AR-9503S-03C (LOT 2501374603), AR-9165-25 (LOT 2501357504). THE (B)(6) 2018 PROCEDURE WAS A REVISION OF ARTHREX PRODUCTS BECAUSE THE PATIENT HAD GLENOID INSTABILITY DUE TO BASEPLATE PLACEMENT ON THE PRIMARY. IT IS UNKNOWN IF THE 2018 REVISION WAS EVER REPORTED TO ARTHREX AS NO DETAILS FROM THE ORIGINAL SURGERY ARE KNOWN TO SEARCH/MATCH PART NUMBERS. THE IMPLANTS PUT IN ON (B)(6) 2018 WERE DONE SO IN A COMPROMISED GLENOID WITH POOR BONE QUALITY. THE PERIPHERAL SCREWS BROKE AND LED TO BASEPLATE FAILURE. THE GLENOSPHERE REMAINED ENGAGED IN THE BASEPLATE. THERE WAS SIGNIFICANT CORROSION OF THE HUMERAL POLY INSERT. THE GLENOID COMPONENTS FAILED NEARLY TWO YEARS AGO BUT THE PATIENT WAITED UNTIL (B)(6) 2020 TO HAVE A REVISION SURGERY. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON ATTRIBUTED THE FAILURE TO PUTTING THE BASEPLATE ON HER ORIGINAL REVERSE PROCEDURE TOO SUPERIOR ON THE FACE OF THE GLENOID WITH S

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10482754 ↗
• InjuryApr 15, 2020Break

  IT WAS REPORTED THAT DURING IMPLANT TO SECURED THE BASEPLATE, THE AR-9145-36 SCREW BROKE OFF AT THE HEAD. THE DISTAL END REMAINS IN THE PATIENT AND THE BASEPLATE IS SECURED WITH TWO OTHER SCREWS. THE CASE WAS A REVERSE TOTAL SHOULDER. UPDATE INFO 04/07/2020: THE SITE WAS PREDRILLED WITH AN AR-9145K PERIPHERAL SCREW DRILL, 2.5 DRILL BIT AND A STRYER DRILL. THERE WAS NO TORQUE INDICATOR USED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9963761 ↗
• InjuryMar 9, 2020Break

  IT WAS REPORTED THAT DURING A LEFT SHOULDER RTSA PROCEDURE, THE SURGEON WAS INSERTING THE INFERIOR SCREW OF THE UNIVERSAL BASEPLATE. INITIALLY, THE BIT HAD THE TORQUE DRIVER ON IT; HE INSERTED IT WITH ABOUT 5MM LEFT AND TOOK OFF THE TORQUE WRENCH. HE PROCEEDED TO INSERT THE SCREW AND WITH ABOUT 2MM LEFT BEFORE IT WAS SEATED, THE TIP OF THE BIT BROKE OFF IN THE HEAD OF THE SCREW. THE BIT WAS UNUSABLE AND THE SCREW WAS STILL PROUD. THE SURGEON THEN ATTEMPTED TO USE A DENTAL PIC AND A SCREW REMOVAL SET TO DISLODGE THE PIECE OF THE BIT THAT WAS STILL RETAINED IN THE HEAD OF THE SCREW WHICH DID NOT WORK. HE EVENTUALLY USED A METAL CUTTING BURR WHICH ALSO DID NOT WORK. AFTER TALKING THROUGH OPTIONS HE DECIDED TO USE THE SAME BURR AND CUT OFF THE TOP OF THE SCREW. HE TRIALED A GLENOSPHERE AND FOUND NO ISSUE WITH THE IMPLANT SEATING PROPERLY SO THE CASE FINISHED WITH NO FURTHER ISSUES. ADDITIONAL INFORMATION PROVIDED 02/19/2020: THE SURGEON WAS AWARE THAT TAKING THE TORQUE DRIVER OFF WAS NOT THE BEST IDEA. IT WAS ON THE BIT WHEN HE FIRST STARTED INSERTING THE LOCKING SCREWS. PATIENT IS A MALE, (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9808430 ↗
• InjuryFeb 26, 2020Break; Difficult to Remove

  IT WAS REPORTED DURING A REVISION TOTAL SHOULDER REPLACEMENT PROCEDURE THE AR-9145-36 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW BROKE AT THE HEAD/ SHAFT JUNCTION UPON INSERTION. THE REP REPORTED THE SCREW HEAD WAS RETRIEVED, BUT THE SHAFT WAS RETAINED IN THE BONE. THE HEX SCREW DRIVER WAS USED TO INSERT THE SCREW. THE RETRIEVED BROKEN SCREW HEAD WILL BE RETURNING FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9756780 ↗
• InjuryMar 21, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2018. 9 MONTHS POST-OP, ON (B)(6) 2019, THE PATIENT WAS SEEN BY THEIR SURGEON FOR A FOLLOW-UP VISIT WHERE AN X-RAY WAS TAKEN TO DETERMINE PROGRESS. THE X-RAY SHOWED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLOCATED. THE PATIENT STATED THAT NO TRAUMA HAD OCCURRED. A COPY OF THE X-RAY IS UNABLE TO BE OBTAINED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2019 AND THE FOLLOWING DEVICES WERE ALL EXPLANTED: AR-9145-30 / LOT: 170156313, AR-9145-36 / LOT: 170139313, AR-9504M / LOT: 140119609, AR-9503M-06 / LOT: 160010109, AR-9120-01 / LOT: 170145515, AND AR-9165-20 / LOT: 150008108. THE SURGEON SWITCHED TO AN RTSA AND IMPLANTED THE FOLLOWING: AR-9502-39ARCA / LOT: 261519 AND AR-9550-19RCA / LOT: 10031668. ADDITIONAL INFORMATION PROVIDED 3/29/2019: THE AR-9145-30 SCREW BROKE UPON REMOVAL OF HARDWARE. TIP WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8440363 ↗
• InjuryFeb 6, 2019Break

  IT WAS REPORTED VIA E-MAIL THAT DURING AN APEX WITH UNIVERSAL GLENOID SURGERY THE SCREW BROKE ON INSERTION. THERE WAS NO ADVERSE EFFECT NOTICED BUT THE BROKEN PART OF THE SCREW WAS LEFT IN THE PATIENT. UPDATE 22 JAN 2019: THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WHICH WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8310996 ↗
• InjuryOct 8, 2018Break

  IT WAS REPORTED THAT DURING A RTSA PROCEDURE, THE PERIPHERAL LOCKING SCREW, AR-9145-36, BROKE DURING INSERTION INTO THE GLENOID BASEPLATE. WHAT WAS LEFT OF THE SCREW IN THE GLENOID WAS LEFT IN ORDER TO NOT FRACTURE THE GLENOID. THE BROKEN PIECE WAS SECURED IN THE BASEPLATE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7943045 ↗