P.F.C. 85-3965Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295207801), received between Nov 30, 2018 and Aug 19, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DM LINER TRIAL BROKE, BLACK POLY EXTRACTOR TIP BROKE OFF, T-HANDLE AND CORKSCREW KEEP DISCONNECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841400 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT HANDLE PORTION OF THE T HANDLE BROKE WHILE TURNING A SCREW. NOTHING WAS LEFT IN PATIENT. ALL PIECES WERE RECOVERED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 20838069 ↗
• MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE T-HANDLE AND AWL/CANAL FINDER WILL NOT COME APART. THE HOSPITAL HAS SENT IT DOWN TO BIO-MED AND IT STILL WON'T COME APART. THE HANDLE WAS ALMOST BRAND NEW AND EVERY TIME IT WAS USED IT DIDN'T CLICK IN PROPERLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605089 ↗
• MalfunctionNov 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SROM WHITE SLEEVE WOULD NOT CONNECT TO ANY OF THE CONE MILLING REAMERS. THE WHITE T HANDLE WOULD NOT CONNECT TO ANY OF THE DISTAL REAMERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107133 ↗
• MalfunctionApr 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUP INSERTER WILL NOT ACCEPT A TRIAL. THE T-HANDLE WILL NOT LOCK INTO ANY REAMERS AND ADAPTER SEEMS TO BE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16745298 ↗
• MalfunctionMar 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ADAPTER WILL NOT ADAPT TO REAMERS OR CANAL FINDER. THERE WERE NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657938 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED THAT THE IMPACTOR HANDLE HAS A CRACK IN IT SO STERILE PROCESSING CANNOT CLEAN THOROUGHLY AROUND IT. T-HANDLE BROKE AT THE END TIP WHERE IT CONNECTS WHEN DOCTOR PUT IT ON AN ACETABULAR REAMER. NOTHING LEFT IN PATIENT FOR EITHER ITEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521300 ↗
• MalfunctionJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE T HANDLE SLIPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672147 ↗
• MalfunctionNov 30, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON WAS USING THE T-HANDLE TO REAM THE FEMORAL CANAL AND THE T-HANDLE WAS NOT TURNING THE REAMERS ANYMORE AND THE T-HANDLE ADAPTER WAS STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119559 ↗