NA 02.212.056Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982055217), received between Aug 11, 2022 and Aug 11, 2022 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K000684); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214548 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214547 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214520 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214514 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214497 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214491 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214473 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214464 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214439 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT SCREWS FROM A LOCKING COMPRESSION (LCP) EXTRAARTICULAR DISTAL HUMERUS PLATING FAILED POSTOPERATIVELY. BASED ON THE X-RAY, IT IS EVIDENT THAT THE SCREW HEADS WERE BROKEN AND THE IMPLANT FAILED. ACCORDING TO SURGEON, THE PATIENT DOES NOT WISH TO UNDERGO A REVISION AT THIS STAGE. THE INITIAL SURGERY WAS PERFORMED SIX WEEKS AGO, AND THE PATIENT WAS DOING WELL. ACCORDING TO THE PATIENT, NO EXTERNAL FORCES EXERTED ON THE IMPLANT CAUSED IT TO MOVE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 56MM. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15214408 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,