NA 309.370Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982185723), received between Apr 30, 2021 and Apr 22, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2024Break; Break

  EACH INSTRUMENT IS COMPOSED OF 1 PART. THE 309.038 AND 309.035 WERE STUCK TOGETHER. 309.370 ALSO SNAPPED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE SPARECENTERPIN F/309.035 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19158129 ↗
• MalfunctionDec 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT DURING THE SURGERY, AT THE TIME OF REMOVING ONE OF THE SCREWS THE TIP OF REFERENCE (REMOVED PRODUCT CODE) WAS SPLIT, IN THE PHOTOS THE BROKEN PIECE AND ITS OTHER HALF WERE RECORDED. THERE WAS NO DISCOMFORT WITH THE SPECIALIST. THERE WAS NO CONSIDERABLE DELAY. SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE PIECES. THERE WAS NO DIRECT INVOLVEMENT IN THE PATIENT, THE OTHER PART OF THE PIECE WAS SUCCESSFULLY RECOVERED. THIS REPORT IS FOR ONE (1) SPARECENTERPIN F/309.035 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18252293 ↗
• InjuryJan 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT THE REAMER TUBE WAS BROKEN DURING THE REVISION SURGERY. THIS PC REPORTS THAT THE CORTEX SCREW WAS BROKEN AFTER THE PRIMARY SURGERY. IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE MPT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE CORTEX SCREW WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNK - SCREWS: CORTEX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16213914 ↗
• InjuryAug 11, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT DURING THE PROCEDURE, TREPANATION WAS BEING PERFORMED ON THE BONE AND THE PIECE BROKE INTO TWO FRAGMENTS, THEY DID NOT REMAIN IN THE PATIENT'S BONE, THE BROKEN FRAGMENTS WERE NOT RECOVERED. THERE WAS NO DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED . THE PATIENT IS IN GOOD CONDITION. THIS REPORT IS FOR ONE (1) SPARECENTERPIN F/309.035 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15213733 ↗
• MalfunctionApr 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 SOME INSTRUMENTS THAT WERE BROKEN DURING A CASE. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED OR IF THEY WERE RETRIEVED. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED AND IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) SPARE CENTERING PIN HOLLOW REAMR(309.035). THIS REPORT IS 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755554 ↗