Arthrex® AR-9145-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867057746), received between Oct 1, 2018 and Mar 19, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ECLIPSE WITH UNIVERSAL GLENOID SURGERY DURING IMPLANTATION OF THE UNIVERSAL GLENOID BASEPLATE THE INFERIOR PERIPHERAL SCREW GOT JAMMED. WHEN TRYING TO SCREW IT IN, THE HEAD OF THE SCREWDRIVER BROKE OFF AND GOT STUCK IN THE SCREW HEAD. THIS HAD TO BE REMOVED USING THE OPERACE SYSTEM. THE SCREW HEAD BROKE OFF IN THE PROCESS. THE REST OF THE SCREW REMAINED IN THE PATIENT AND THE BASEPLATE WAS LEFT AS IT WAS. THE INLAY WAS THEN PLACED ON TOP AND THE SURGERY WAS COMPLETED AS NORMAL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18935788 ↗
• InjurySep 10, 2020Break

  IT WAS REPORTED THAT DURING A UNIVERSAL GLENOID PROCEDURE TWO AR-9145-42, UNI GLENOID PERIPHERAL LOCKING SCREWS (LOT 18.00584) BROKE DURING INSERTION. BOTH SCREWS BROKE FROM THE HEAD AS THE SURGEON TRIED TO RETRIEVE THEM, SMALL PIECES KEPT BREAKING OFF. THE SURGEON PROCEEDED TO REMOVE THE CENTRAL SCREW ALONG WITH THE BASE PLATE AND LEFT ABOUT HALF TO A QUARTER OF THE SCREW IN THE PATIENT AS THE PORTION COULD NOT BE RETRIEVED. THE SURGEON HAD TO CHANGE THE TECHNIQUE FROM A UNIVERSAL GLENOID TO A REVERSE MODULAR GLENOID . IN ORDER TO MAKE THE CHANGE THE SURGEON ALSO HAD TO REMOVE THE FOLLOWING DEVICES (QUANTITY ONE EACH) WHICH HAD JUST BEEN IMPLANTED: AR-9165-25 UNIVERSAL GLENOID CENTRAL SCREW (LOT 18.01267), AR-9145-24 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW (LOT 18.02031) AND AR-9120-03 UNIVERSAL GLENOID BASEPLATE (LOT 170014815). PATIENT BONE QUALITY WAS REPORTED TO BE GOOD AND HARD. THE PATIENT WAS A YOUNG MALE. REPORTER STATES THE SURGEON USED THE PROPER IMPLANT TECHNIQUE WITH THE PROPER DRILL BIT. ALL SCREWS WERE DISPOSED OF AT TIME OF PROCEDURE. BASEPLATE WAS KEPT TO RETURN FOR EVALUATION.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 10515529 ↗
• InjuryJul 15, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT TWO PERIPHERAL SCREWS OF THE PROSTHESIS BROKE POST OP. IT WAS FURTHER REPORTED THAT THE BREAKAGE WAS NOT THE RESULT OF A TRAUMA. INITIAL SURGERY WAS AN INVERSE SHOULDER PROSTHESIS, PERFORMED ON (B)(6) 2019. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. ALL FRAGMENTS HAVE BEEN REMOVED DURING THE REVISION SURGERY. DURING THE REVISION, A SPACER WAS IMPLANTED. NO FURTHER INFORMATION RECEIVED. UPDATE 29-JUNE-2020: THE CENTRAL SCREW WAS INTACT. BATCH NUMBERS WERE PROVIDED. THE DEVICE BREAKAGE WAS DISCOVERED BY X-RAY. ALL AVAILABLE X-RAYS HAVE BEEN PROVIDED TO ARTHREX. PATIENT HAD REPORTED TO THE SURGEON THAT POST OP AFTERCARE INSTRUCTIONS WERE FOLLOWED. BECAUSE OF AN INFECTION, A CEMENT SPACER WAS IMPLANTED. IT IS EXPECTED THAT THE TOTAL PROSTHETICS WILL BE RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 10279382 ↗
• InjuryDec 10, 2019Break

  IT WAS REPORTED THAT DURING A TSA V RSA PROCEDURE, BOTH 42MM PERIPHERAL LOCKING SCREWS, AR-9145-42 (LOTS: 170167213 AND 18.00840) BROKE WHILE BEING INSERTED INTO THE BASEPLATE. THE SCREWS HAD NOT YET ENGAGED WITH THE BUSHING ON THE BASEPLATE WHEN THEY BROKE. AFTER THE SECOND SCREW BROKE, THE DECISION WAS MADE TO REMOVE THE ENTIRE BASEPLATE. UPON DOING SO, IT WAS DISCOVERED THAT THE SCREWS HAD BROKEN DEEP ENOUGH WITHIN THE BONE. THE SURGEON DECIDED TO LEAVE THE DISTAL TIPS IN PLACE AND USE AN MGS IMPLANT. THE REMAINING PORTION OF THE BROKEN SCREWS WERE DEEP ENOUGH WITHIN BONE THEY DID NOT INTERFERE WITH MGS BONY PREP AND STANDARD SURGICAL TECHNIQUE WAS CARRIED OUT FROM THAT POINT FORWARD.

  Patient problems: Foreign Body In Patient

  MAUDE report 9443876 ↗
• InjuryDec 10, 2019Break

  IT WAS REPORTED THAT DURING A TSA V RSA PROCEDURE, BOTH 42MM PERIPHERAL LOCKING SCREWS, AR-9145-42 (LOTS: 170167213 AND 18.00840) BROKE WHILE BEING INSERTED INTO THE BASEPLATE. THE SCREWS HAD NOT YET ENGAGED WITH THE BUSHING ON THE BASEPLATE WHEN THEY BROKE. AFTER THE SECOND SCREW BROKE, THE DECISION WAS MADE TO REMOVE THE ENTIRE BASEPLATE. UPON DOING SO, IT WAS DISCOVERED THAT THE SCREWS HAD BROKEN DEEP ENOUGH WITHIN THE BONE. THE SURGEON DECIDED TO LEAVE THE DISTAL TIPS IN PLACE AND USE AN MGS IMPLANT. THE REMAINING PORTION OF THE BROKEN SCREWS WERE DEEP ENOUGH WITHIN BONE THEY DID NOT INTERFERE WITH MGS BONY PREP AND STANDARD SURGICAL TECHNIQUE WAS CARRIED OUT FROM THAT POINT FORWARD.

  Patient problems: Foreign Body In Patient

  MAUDE report 9443859 ↗
• InjuryOct 1, 2018Break

  IT WAS REPORTED THAT THE SCREW WAS BEING USED TO PUT IN THE BASEPLATE AND THE SCREW BROKE. THE HEAD OF THE SCREW POPPED OUT; AND THE SHAFT OF THE SCREW REMAINS IN THE PATIENT. THE BASEPLATE HAS THE CENTRAL AND PERIPHERAL SCREWS HOLDING IT IN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7923050 ↗