N/A 24-1189Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00841036123130), received between Feb 27, 2019 and Jan 10, 2020 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K121589); they may or may not involve this specific model.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED AN INSTRUMENT CONTAINED BLOOD AND TISSUE FOLLOWING THE CLEANING AND STERILIZATION PROCESS. PROTEIN TEST WAS PERFORMED AND THE TEST RESULT WAS POSITIVE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9578148 ↗
• MalfunctionJan 10, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED AN INSTRUMENT CONTAINED BLOOD AND TISSUE FOLLOWING THE CLEANING AND STERILIZATION PROCESS. PROTEIN TEST WAS PERFORMED AND THE TEST RESULT WAS POSITIVE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9578140 ↗
• MalfunctionJan 10, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED AN INSTRUMENT CONTAINED BLOOD AND TISSUE FOLLOWING THE CLEANING AND STERILIZATION PROCESS. PROTEIN TEST WAS PERFORMED AND THE TEST RESULT WAS POSITIVE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9578137 ↗
• MalfunctionOct 31, 2019Device Contamination with Body Fluid; Device Contamination with Body Fluid

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 9263211 ↗
• MalfunctionJul 8, 2019Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED BY THE SALES ASSOCIATE THAT A TEMPORARY FIXATION SCREW BECAME STUCK IN ONE DRIVER AND ANOTHER DRIVER WAS HARD TO TURN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Information

  MAUDE report 8770061 ↗
• MalfunctionJun 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692528 ↗
• MalfunctionMay 24, 2019Mechanical Jam; Mechanical Jam

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8641909 ↗
• InjuryMay 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Tissue Damage

  MAUDE report 8634370 ↗
• MalfunctionMay 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612677 ↗
• MalfunctionMay 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DRIVER BROKE DURING A CASE. THERE WAS NO PATIENT INJURY AND MINIMAL SURGICAL DELAY. IN ADDITION, THE BLADE REMAINED STUCK IN DRIVER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601220 ↗
• MalfunctionMay 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599620 ↗
• MalfunctionMay 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599577 ↗
• MalfunctionMay 3, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Patient Involvement

  MAUDE report 8577709 ↗
• MalfunctionApr 12, 2019Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 8509094 ↗
• MalfunctionApr 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8481221 ↗
• MalfunctionMar 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED A TEMPORARY FIXATION PIN BECAME IRREVERSIBLY LODGED IN THE CONTRA ANGLE DRIVER. THE SURGEON WAS PLATING LEFT SIDED RIB WITH RIBFIX BLU. THE PIN WAS ABLE TO BE REMOVED FROM THE PATIENT'S BONE WITHOUT DAMAGING THE BONE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429038 ↗
• MalfunctionMar 13, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED TWO DRIVERS ARE STRIPPED. THIS WAS DISCOVERED DURING A REVISION PROCEDURE. THE SURGEON WANTED TO USE THE RIGHT ANGLE DRIVERS BECAUSE HE DID NOT WANT TO OPEN INCISION MORE. THE PROCEDURE WAS COMPLETED BY USING FORCEPS REACHING UNDER THE SKIN AND HOLDING A DIFFERENT BLADE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416124 ↗
• MalfunctionFeb 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED TWO RIGHT ANGLE SCREWDRIVERS HAD TROUBLE ROTATING DURING A RIB FRACTURE CASE. ADDITIONAL SCREWDRIVERS WERE AVAILABLE TO COMPLETE THE CASE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121589. One submission often covers many models, so check the product and lot details in each record.

• Z-1220-2017 · Jan 10, 2017 · Terminated
  1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw