PROCOTYL® PRIME P3SDTOSLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684P3SDTOSL1), received between Sep 29, 2020 and Jan 20, 2021 — classified as 2 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2021Break; Break

  ALLEGEDLY, DURING INSERTION OF THE SCREW, THE TIP OF THE SCREWDRIVER BROKE OF DURING USE. THE REMNANT REMAINED IN THE CUP BECAUSE IT WAS NOT ABLE TO BE REMOVED. ADDITIONAL INFORMATION RECEIVED ON 11/11/2020 FROM (B)(6): INCIDENT DESCRIPTION WAS OBTAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11203220 ↗
• InjuryJan 11, 2021Break; Break

  ALLEGEDLY, WHILE IMPLANTING CUP, SCREW BECAME STUCK. PHYSICIAN TRIED TO TIGHTEN SCREW, AND THE TIP OF THE DRIVER BROKE OFF INTO THE HEAD OF THE SCREW. IT WAS UNABLE TO BE REMOVED AND IS STILL IMPLANTED IN THE PATIENT. KIT NUMBER: SPTHKIT3 (2 PAN).

  Patient problems: Foreign Body In Patient

  MAUDE report 11146471 ↗
• MalfunctionSep 29, 2020Break; Break

  ALLEGEDLY, TIP OF SCREWDRIVER BROKE OFF IN USE INSIDE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 09/11/2020 FROM (B)(6) : CONFIRMATION THAT THE TIP INSTRUMENT REMAINED INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10602753 ↗