S-ROM 53-4107Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295171720), received between Sep 29, 2017 and Jul 15, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2020Break; Material Deformation; Break; Material Deformation

  THE SURGERY WAS PERFORMED ON (B)(6) 2020. DURING THE SURGERY, THE SHAFT PILOT (P/N: 534107) BROKE. THE SURGEON SELECTED DAA BUT THE SURGICAL FIELD¿S EXPANSION WAS BAD, THE SHAFT¿S BREAKAGE OCCURRED WHEN THE SURGEON USED A MILLER CUTTER. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279971 ↗
• MalfunctionJul 10, 2020Break; Entrapment of Device; Break; Entrapment of Device

  BREAKAGE. IT WAS REPORTED THAT DURING THE HIP REPLACEMENT OPERATION,WHEN DID THE "PROXIMAL REAMING", BREAKAGE OCCURRED AT THE THREADED JUNCTION OF THE DISTAL GUIDE ROD AND THE CONICAL REAMER. IT IS NOT KNOWN WHETHER THERE ARE METAL DEBRIS IN THE FRACTURE SITE REMAINED IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE OPERATION. THE OPERATION DELAYED ABOUT 40 MINS. THE PATIENT WAS STABLE AND LEFT FROM HOSPITAL NOW.

  Patient problems: No Code Available

  MAUDE report 10260964 ↗
• MalfunctionApr 23, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA THA. DURING THE SURGERY, WHEN THE SURGEON CONNECTED THE REAMER (P/N: 534700) TO THE SHAFT (P/N: 534107) AND REAMED BONE-MARROW CAVITY, THE SHAFT CAME OFF FROM THE REAMER AND REMAINED IN THE BONE CAVITY. THE SURGEON REMOVED THE SHAFT WITH A LONG PEAN FORCEPS UNDER X-RAY. AFTER THAT, WHEN THE SURGEON REAMED PROXIMAL BONE BECAUSE HE HAD DIFFICULTY IN REDUCING IN THE TRIALING, THE SHAFT CAME OFF FROM THE REAMER AGAIN AND REMAINED IN THE BODY. THE SECOND TIME, IT TOOK TIME TO REMOVE THE SHAFT BECAUSE THE SHAFT CAME OFF AT DEEP POINT OF THE BONE-MARROW CAVITY DESPITE THE NURSE TIGHTEN THE REAMER AND THE SHAFT. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. IT WAS POSSIBLE THAT THE PATIENT WAS INVERSION POSITION WHEN THE SURGEON REAMED. AFTER THE SURGERY, WHEN THE SURGEON CHECKED THE DEVICES, HE COULD NOT INSERT THE SHAFT INTO THE REAMER FOR APPROPRIATELY DEPTH (SOME SOFT TISSUE OR BONE CHIPS MIGHT ADHERE THE SHAFT OR THE REAMER BECAUSE THE DEVICES WERE BEFORE CLEANING.). THE DEVICES HAD NO PROBLEM WHEN THE HOSPITAL CHECKED BEFORE THE SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9991411 ↗
• MalfunctionSep 29, 2017Break; Break

  IT WAS REPORTED THAT THE PILOT SHAFT THREADS BROKE OFF WHILE REAMING THE FEMUR.

  Patient problems: No Information

  MAUDE report 6904723 ↗