NA 03.505.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587013350), received between Jun 21, 2021 and Jun 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, IN ORDER TO MAKE A BURR HOLE, THEY ASSEMBLED THE 90 DEGREE SCREWDRIVER COMPONENTS OUT OF A SCREWDRIVER KIT AND CONNECTED WITH A STRYKER¿S TPS (TOTAL PERFORMANCE SYSTEM). HOWEVER, THE STRYKER DID NOT START AND TRIED ASSEMBLING SPARE SCREWDRIVER COMPONENTS FROM THE SAME KIT, WHICH LEAD TO THE SAME RESULT. THEY TRIED ASSEMBLING THE DEVICE ONE MORE TIME AND IT WORKED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. RCANEINSTR F/REMOVAL OF INSERTS (PRODUCT#: 05.505.003, LOT#: UNK, QUANTITY: 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) SCRHOLDER F/90 SCREWDRIVER OUT INSERT. THIS REPORT IS 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031817 ↗
• MalfunctionJun 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, IN ORDER TO MAKE A BURR HOLE, THEY ASSEMBLED THE 90 DEGREE SCREWDRIVER COMPONENTS OUT OF A SCREWDRIVER KIT AND CONNECTED WITH A STRYKER¿S TPS (TOTAL PERFORMANCE SYSTEM). HOWEVER, THE STRYKER DID NOT START AND TRIED ASSEMBLING SPARE SCREWDRIVER COMPONENTS FROM THE SAME KIT, WHICH LEAD TO THE SAME RESULT. THEY TRIED ASSEMBLING THE DEVICE ONE MORE TIME AND IT WORKED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED. RCANEINSTR F/REMOVAL OF INSERTS (PRODUCT#: 05.505.003, LOT#: UNK, QUANTITY: 1). THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) SCRHOLDER F/90 SCREWDRIVER OUT INSERT. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031816 ↗