Arthrex® AR-1530BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00888867018600), received between Dec 19, 2016 and May 30, 2025 — classified as 12 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (35 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A ANAFAB SL-TAPE REKO SURGERY THE PINS, WHICH HOLD THE SCREW AT THE INSTRUMENT, BROKE OFF WHILE INSERTING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115456 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A ANAFAB SL-TAPE REKO SURGERY THE PINS, WHICH HOLD THE SCREW AT THE INSTRUMENT, BROKE OFF WHILE INSERTING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115051 ↗
• MalfunctionMay 28, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 5/9/2025: THE CASE INVOLVED A SCAPHOLUNATE RECONSTRUCTION PROCEDURE. DURING THE SURGERY, NOT ALL FRAGMENTS WERE RETRIEVED, NECESSITATING THE USE OF A NEW AR-1530BC BIOCOMPOSITE-TENODESIS SCREW. DETAILS REGARDING ANY DELAYS IN THE CASE REMAIN UNKNOWN. ADDITIONALLY, IT IS UNCLEAR WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22094773 ↗
• MalfunctionMay 28, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 5/9/2025: THE CASE INVOLVED A SCAPHOLUNATE RECONSTRUCTION PROCEDURE. DURING THE SURGERY, NOT ALL FRAGMENTS WERE RETRIEVED, NECESSITATING THE USE OF A NEW AR-1530BC BIOCOMPOSITE-TENODESIS SCREW. DETAILS REGARDING ANY DELAYS IN THE CASE REMAIN UNKNOWN. ADDITIONALLY, IT IS UNCLEAR WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22094643 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN SLIC WRIST LIGAMENT REPAIR SURGERY THE DRIVER BROKE OFF INSIDE THE SCREW AND THE FRAGMENT REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20384501 ↗
• MalfunctionJun 28, 2024Break; Break

  ON 06/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-1530BC BIOCOMPOSITE-TENODESIS¿ SCREW WITH HANDLED INSERTERS TIPS BROKE OFF. THIS OCCURRED DURING A HAND/WRIST - 360 SL RECONSTRUCTION ON (B)(6) 2024 THE SURGEON DRILLED 2.5 MM AND 3.0 MM IN THE SCAPHOUD AND LUNATE, RESPECTIVELY, PER THE TECHNIQUE GUIDE. THE SURGEON THEN IMPLANTED TWO 3 X 8 MM TENODESIS SCREWS. HOWEVER, DESPITE ¿PRIMING¿ THE SCREW AND DRIVER, THE DRIVER COULD NOT BE PULLED OUT FROM THE TUNNEL WITHOUT CONSIDERABLE FORCE THAT LEFT THE 8MM TIP OF BOTH DRIVERS INSIDE THE SCREW. THE PATIENT IS LEFT WITH UNINTENDED METAL IMPLANTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19633554 ↗
• MalfunctionJun 28, 2024Break; Break

  ON (B)(6) 2024 IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06591357 THAT (2) AR-1530BC BIOCOMPOSITE TENODESIS¿ SCREW WITH HANDLED INSERTERS TIPS BROKE OFF. THIS OCCURRED DURING A HAND/WRIST 360 SL RECONSTRUCTION ON (B)(6) 2024 THE SURGEON DRILLED 2.5 MM AND 3.0 MM IN THE SCAPHOUD AND LUNATE, RESPECTIVELY, PER THE TECHNIQUE GUIDE. THE SURGEON THEN IMPLANTED TWO 3 X 8 MM TENODESIS SCREWS. HOWEVER, DESPITE ¿PRIMING¿ THE SCREW AND DRIVER, THE DRIVER COULD NOT BE PULLED OUT FROM THE TUNNEL WITHOUT CONSIDERABLE FORCE THAT LEFT THE 8MM TIP OF BOTH DRIVERS INSIDE THE SCREW. THE PATIENT IS LEFT WITH UNINTENDED METAL IMPLANTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19633265 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 1/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1530BC HANDLE INSERTER BROKE WHEN THE BIOCOMPOSITE-TENODESIS SCREW WAS REMOVED FROM THE DRIVER. THIS WAS DISCOVERED DURING A THUMB MC ARTHROPLASTY PROCEDURE ON (B)(6) 2022. SURGEON USED A NEW PRODUCT AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION RECEIVED 1/13/2022: DEVICE FAILURE OCCURRED OUTSIDE OF THE PATIENTS BODY AND NOTHING BROKE INSIDE. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484626 ↗
• MalfunctionMay 7, 2024Break; Break

  ON 11/16/2021, IT WAS REPORTED BY A DISTRIBUTOR VIA E-MAIL THAT AN AR-1530BC TENODESIS SCREW STEM BROKE UPON INSERTION, LEAVING THE REMAINDER OF THE STEM INSIDE THE SCREW. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-1530BC.

  Patient problems: Insufficient Information

  MAUDE report 19257695 ↗
• MalfunctionMay 2, 2024Fitting Problem; Fitting Problem

  ON 4/1/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1530BC BIOCOMPOSITE-TENODESIS SCREW WITH HANDLED INSERTER PULLED THE SCREW OUT WHEN REMOVING THE HANDLED INSERTER. THE SCREW WAS WELDED TO THE INSERTER. SURGEON WAS ABLE TO COMPLETE CASE WITH A 3.5MM SWIVELOCK AND TAKING OFF THE EYELET TO TENODESIS THE TENDON AND SUTURE. THIS WAS DISCOVERED A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 4/4/2022: THIS WAS DISCOVERED DURING AN INTEROSSEOUS SCAPHOLUNATE RECONSTRUCTION AND NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230916 ↗
• InjuryMar 21, 2024Break; Break

  ON 03/07/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA E-MAIL THAT (2) AR-1530BC BIOCOMPOSITE-TENODESIS¿ SCREW WITH HANDLED INSERTER TIP OF BOTH DRIVERS BROKE OFF INSIDE THE SCREW, INSIDE THE PATIENT. THIS OCCURRED DURING A CASE WHERE THE SURGEON DRILLED 2.5 MM AND 3.0 MM IN THE SCAPHOUD AND LUNATE, RESPECTIVELY, AS PER THE TECHNIQUE GUIDE. THE SURGEON THEN IMPLANTED TWO 3 X 8 MM TENODESIS SCREWS. HOWEVER, DESPITE ¿PRIMING¿ THE SCREW AND DRIVER, THE DRIVER COULD NOT BE PULLED OUT FROM THE TUNNEL WITHOUT CONSIDERABLE FORCE, THE FORCE THAT LEFT THE 8MM TIP OF BOTH DRIVERS INSIDE THE SCREW, INSIDE THE PATIENT. THEY NEEDED TO BAIL ON THE INTERNALBRACE AUGMENTATION (THE MAIN PURPOSE OF THE PROCEDURE), AND THE PATIENT WAS LEFT WITH UNINTENDED METAL IMPLANTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18951434 ↗
• InjuryMar 21, 2024Break; Break

  ON 03/07/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA E-MAIL THAT (2) AR-1530BC BIOCOMPOSITE-TENODESIS¿ SCREW WITH HANDLED INSERTER TIP OF BOTH DRIVERS BROKE OFF INSIDE THE SCREW, INSIDE THE PATIENT. THIS OCCURRED DURING A CASE WHERE THE SURGEON DRILLED 2.5 MM AND 3.0 MM IN THE SCAPHOUD AND LUNATE, RESPECTIVELY, AS PER THE TECHNIQUE GUIDE. THE SURGEON THEN IMPLANTED TWO 3 X 8 MM TENODESIS SCREWS. HOWEVER, DESPITE ¿PRIMING¿ THE SCREW AND DRIVER, THE DRIVER COULD NOT BE PULLED OUT FROM THE TUNNEL WITHOUT CONSIDERABLE FORCE, THE FORCE THAT LEFT THE 8MM TIP OF BOTH DRIVERS INSIDE THE SCREW, INSIDE THE PATIENT. THEY NEEDED TO BAIL ON THE INTERNALBRACE AUGMENTATION (THE MAIN PURPOSE OF THE PROCEDURE), AND THE PATIENT WAS LEFT WITH UNINTENDED METAL IMPLANTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18951425 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT DURING A S/L LIGAMENT RECONSTRUCTION SURGERY THE SCREWDRIVER BROKEN OFF IN THE SCREW. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (FIBER TAPE). THE SURGICAL PROCEDURE HAD TO BE CHANGED TO AN OPEN TECHNIQUE ON BOTH SIDES AND A KNOTTED FIBERTAPE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. ***UPDATE AVOE 14-DEC-2023 IT WAS CONFIRMED THAT THE DRILL-BIT FROM THE KIT AR-1530DS WAS USED TO PREPARE THE BONE. THE BONE QUALITY WAS PRETTY GOOD AND THUS WASN'T A PROBLEM. THE INSTRUMENT BROKE WHILE DRILLING THE TENO-SCREW IN, BUT THE BROKEN METAL PART NEVER TOUCHED THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18443305 ↗
• InjuryJul 3, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT THE TIP OF THE DRIVER FROM AN AR-1530BC BIOCOMPOSITE-TENODESIS SCREW WITH HANDLED INSERTER BROKE. AFTER THE SCREW WAS IMPLANTED, THE DRIVER WAS REMOVED, AND THE TIP BROKE; IT WAS LEFT INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A RIGHT THUMB CM ARTHROPLASTY PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17246378 ↗
• MalfunctionApr 17, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1530BC BIOCOMPOSITE-TENODESIS HANDLED INSERTER TIP BROKE OFF, AND STAYED IN THE SCREW WHEN IT WAS IMPLANTED. THE SURGEON ATTEMPTED TO REMOVE IT BUT, AFTER FAILING TO DO SO DECIDED TO LEAVE IT. THIS WAS DISCOVERED DURING A PLANTER PLATE REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16750925 ↗
• MalfunctionJan 9, 2023Break; Positioning Problem

  ON 12/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A FORKED TIP SWIVELOCK DID NOT SEAT WELL IN THE PATIENT. AN AR-1530BC BIO-COMPOSITE-TENODESIS SCREW WAS OPENED AND THE TIP OF THE DRIVER BROKE OFF WITHIN THE SCREW DURING INSERTION. THE SCREW WAS IMPLANTED SUCCESSFULLY, AND THE METAL INSERTER TIP REMAINED INSIDE THE SCREW. THIS WAS DISCOVERED DURING AN INTERPOSITION ARTHROPLASTY OF THE FIRST MTPJ PROCEDURE ON (B)(6) 2022, WHILE SECURING THE THIRD ANCHORING POINT OF THE ARTHROFLEX DORSALLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16120526 ↗
• MalfunctionJun 27, 2022Device Slipped; Output Problem

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1530BC BIOCOMPOSITE-TENODESIS SCREW ANCHOR PULLED OUT FROM IMPLANTATION SITE. SURGEON PREPARED A 3MM BONE SOCKET AND WHEN ANCHOR WAS INSERTED, IT SLIPPED AND COULD NOT BE FIXED. A NEW PRODUCT WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A THUMB CM ARTHROPLASTY PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 3/28/2022: PER ARTHREX EMPLOYEE, THE ANCHOR DID NOT SEAT AND COULD NOT BE USED TO COMPLETE THE CASE, ANOTHER ONE WAS OPENED TO FINISH CASE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: Insufficient Information

  MAUDE report 14828523 ↗
• MalfunctionMay 31, 2022Break; Entrapment of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-1530BC INSERTERS TIP BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A HAND AND WRIST PROCEDURE WHEN INSERTING THE SCREW THE TIP OF THE INSERTER BROKE OFF, AND REMAINED STUCK IN THE SCREW. THE SCREW SAT FINE, AND WAS LEFT IN THE PATIENT WITH THE BROKEN FRAGMENT STUCK IN IT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14546924 ↗
• MalfunctionJan 11, 2022Break

  ON 12/23/2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA E-MAIL THAT A AR-1530BC BIO-COMPOSITE-TENODESIS INSERTER BROKE. THIS OCCURRED ON (B)(6) 2021 DURING AN UNKNOW PROCEDURE AFTER INSERTING THE SCREW INTO THE BONE SOCKET, THE INSERTER WAS BROKE. NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13225893 ↗
• MalfunctionJan 11, 2022Break

  IT WAS REPORTED THAT DURING AN UCL RECONSTRUCTION ON THE THUMB THE TENODESIS SCREW BROKE OFF DURING INSERTION. THE BROKEN PIECE REMAINS INSIDE THE PATIENT. METAL ROD IS ALSO INSTALLED IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 03-JAN-2021: THE IMPLANT BROKE AFTER FULL INSERTION TO INTENDED DEPTH. AS THE SCREW ON THE AR-1530BC IS SITTING OVER A SMALL METAL ROT, WHEN THE ITEM BROKE INSIDE THE PATIENT, A PIECE OF THE METAL ROD ALSO BROKE OFF AND IS REMAINING IN THE SCREW IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13225859 ↗
• MalfunctionJan 4, 2022Break

  ON 12/05/2021, IT WAS REPORTED BY AN ARTHREX REPRESENTATIVE VIA E-MAIL THAT AN AR-1530BC BIOCOMPOSITE-TENODESIS SCREW WAS USED IN RECONSTRUCTION OF THE LATERAL COLLATERAL LIGAMENT OF THE HALLUX ON (B)(6) 2021. DURING INSERTION OF THE SCREW INTO THE PROXIMAL PHALANX, THE INSERTER WAS BROKEN, AND THE BROKEN PIECE FELL OFF INTO THE SCREW. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PIECE BUT THE SCREW WAS FIXATED INTO THE PATIENT AND THE CASE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13152743 ↗
• InjuryNov 30, 2021Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PLANTAR PLATE REPAIR WITH CPR KIT AND AN EDB TRANSFER USING THE MINI BIOTENODESIS MULTIPLE ISSUES OCCURRED WITH SEVERAL DEVICES. THE SURGEON REPORTED THAT CPR WENT WELL UNTIL FIXING THE WEIL¿S OSTEOTOMY. INITIALLY THE SURGEON STRUGGLED TO SNAP OFF THE TWIST OFF SCREW. THE FIRST ONE HE ONLY PARTIALLY BENT IT ON HEN ENGAGED THE DRILL SO IT SPAN AROUND. HE THEN TRIED ANOTHER SCREW IN A DIFFERENT POSITION AND IT SEEMED FINE. AFTER THE FIRST SCREW FOR THE EDB TRANSFER WENT IN FOUND THE SECOND TENODESIS SCREW DID NOT. THE SURGEON KEPT PUSHING AND TWISTING BUT NO ENGAGEMENT BEYOND A CERTAIN POINT. SCREWDRIVER SNAPPED LEAVING A PIECE OF WIRE EMBEDDED IN THE SCREW. HE THEN TRIED TO TWIST FURTHER BUT SCREW CAME OUT. HE TRIED ANOTHER ONE BUT AFTER INSERTING THE SCREWDRIVER HANDLE WOULD NOT DISENGAGE FROM THE SCREW. THE WIRE HOLDING THE TENDON FOR TRANSFER SNAPPED AND THEREFORE THIS PART OF THE PROCEDURE DID NOT WORK. THE SURGEON TRIED ANOTHER TWIST OFF BUT IT DID NOT SNAP. IT WAS FURTHER REPORTED THAT DUE TO THESE FAILURES THE BONE WAS DAMAGED. THIS MEANT THERE WASN¿T SPACE OR QUALITY OF BONE LEFT TO FINISH THE PROCEDURE. ON 17-NOV-2021 UPDATE DW: FURTHER INFORMA

  Patient problems: Pain

  MAUDE report 12897832 ↗
• InjuryNov 30, 2021Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PLANTAR PLATE REPAIR WITH CPR KIT AND AN EDB TRANSFER USING THE MINI BIOTENODESIS MULTIPLE ISSUES OCCURRED WITH SEVERAL DEVICES. THE SURGEON REPORTED THAT CPR WENT WELL UNTIL FIXING THE WEIL¿S OSTEOTOMY. INITIALLY THE SURGEON STRUGGLED TO SNAP OFF THE TWIST OFF SCREW. THE FIRST ONE HE ONLY PARTIALLY BENT IT ON HEN ENGAGED THE DRILL SO IT SPAN AROUND. HE THEN TRIED ANOTHER SCREW IN A DIFFERENT POSITION AND IT SEEMED FINE. AFTER THE FIRST SCREW FOR THE EDB TRANSFER WENT IN FIND THE SECOND TENODESIS SCREW DID NOT. THE SURGEON KEPT PUSHING AND TWISTING BUT NO ENGAGEMENT BEYOND A CERTAIN POINT. SCREWDRIVER SNAPPED LEAVING A PIECE OF WIRE EMBEDDED IN THE SCREW. HE THEN TRIED TO TWIST FURTHER BUT SCREW CAME OUT. HE TRIED ANOTHER ONE BUT AFTER INSERTING THE SCREWDRIVER HANDLE WOULD NOT DISENGAGE FROM THE SCREW. THE WIRE HOLDING THE TENDON FOR TRANSFER SNAPPED AND THEREFORE THIS PART OF THE PROCEDURE DID NOT WORK. THE SURGEON TRIED ANOTHER TWIST OFF BUT IT DID NOT SNAP. IT WAS FURTHER REPORTED THAT DUE TO THESE FAILURES THE BONE WAS DAMAGED. THIS MEANT THERE WASN¿T SPACE OR QUALITY OF BONE LEFT TO FINISH THE PROCEDURE. 17-NOV-2021 UPDATE: FURTHER INFORMATION WE

  Patient problems: Pain

  MAUDE report 12896853 ↗
• MalfunctionNov 22, 2021Break; Entrapment of Device

  ON 11/05/2021 IT WAS REPORTED BY AN ARTHREX REPRESENTATIVE VIA SEMS THAT AN AR-1530BC, WAS USED IN RECONSTRUCTION OF THE RADIAL COLLATERAL LIGAMENT OF THE INDEX FINGER ON (B)(6) 2021. DURING INSERTION OF THE SCREW INTO THE METACARPAL BONE, THE DRIVER BROKE AND THE BROKEN PIECE REMAINED IN THE SCREW. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN PIECE, AND THE PIECE IS STILL LEFT IN THE PATIENT'S BODY. THE CASE WAS COMPLETED USING THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12854360 ↗
• MalfunctionSep 28, 2021Break

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE DEVICE AR-1530BC (LOT 123197887) THE SCREWDRIVER ATTACHMENT FROM THE HANDLED INSERTER BROKE OFF IN THE SCREW. THE BROKEN OFF PIN REMAINED INSIDE THE PATIENT WITH THE SCREW. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE ON 13-SEP-2021: IT WAS CONFIRMED THAT THE AR-8978P-1 DEVICE WAS USED FIRST AND WHEN IT BROKE, THE AR-1530BC DEVICE WAS INSERTED INTO THE SAME BONE TUNNEL, WHICH ALSO BROKE. ALL FRAGMENTS OF THE AR-8978P-1 WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540254 ↗