NA 311.01.96Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982187208), received between Aug 30, 2017 and Jun 29, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2022Crack; Crack

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6),2022 THE HANDLE CRACKED ON AN UNKNOWN REASON. NO PATIENT CONSEQUENCES WAS REPORTED DUE TO THIS EVENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14857340 ↗
• MalfunctionMar 29, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A METATARSAL FRACTURE PROCEDURE, THE TINES OF THE DOUBLE DRILL GUIDE WERE BENT AND SHEARED METAL OFF OF THE DRILL BIT. ONE (1) SCREWDRIVER HANDLE BROKE. THE TIPS OF ONE (1) 1.3/1.5 DEPTH GAUGE AND ONE (1) 2.0/2.4 DEPTH GAUGE WERE DISTORTED. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. FRAGMENTS WERE GENERATED AND EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SET OF DEVICES. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584565 ↗
• MalfunctionJan 4, 2021Crack; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON RESETTING AND PREPPING A TRAY FOR SURGERY, THE PHENOLIC RESIN HANDLE WITH MINI QUICK COUPLING OF THE SCREWDRIVER WAS CRACKED IN THREE (3) PLACES AND ALMOST READY TO FALL APART. IT CAN NO LONGER BE USED IN SURGERY SAFELY. THIS INCIDENT DID NOT AFFECT THE PATIENT. THERE IS NO PATIENT CONSEQUENCE. DURING THE INVESTIGATION IT WAS NOTED, THE HANDLE WAS BROKEN. THIS REPORT IS FOR A HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11109920 ↗
• MalfunctionMar 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE WITH MINI QUICK COUPLING WOULD NOT HOLD ONTO THE SCREWDRIVER SHAFT DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: SCREWDRIVER SHAFT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832115 ↗
• MalfunctionOct 25, 2019Device Handling Problem; Device Handling Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9240137 ↗
• MalfunctionOct 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT INSTRUMENTS WERE FOUND BROKEN IN INSPECTION TIME. THERE IS NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 6 OF 09 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192761 ↗
• MalfunctionOct 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT INSTRUMENTS WERE FOUND BROKEN IN INSPECTION TIME. THERE IS NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 8 OF 09 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192467 ↗
• MalfunctionOct 14, 2019Break; Break

  IT WAS REPORTED THAT DURING FIELD INSPECTION AT THE STERILE PROCESSING DEPARTMENT ON (B)(6) 2019, THE HANDLE OF THE MINI QUICK COUPLING HANDLE WAS DISCOVERED BROKEN. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9185958 ↗
• MalfunctionOct 26, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, FIVE (5) HANDLES WITH MINI QUICK COUPLING WITH THE PHENOLIC, WOODEN STYLE HANDLES ARE CAUSING BROWN STAINS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8008675 ↗
• MalfunctionOct 26, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, FIVE (5) HANDLES WITH MINI QUICK COUPLING WITH THE PHENOLIC, WOODEN STYLE HANDLES ARE CAUSING BROWN STAINS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8008660 ↗
• MalfunctionOct 26, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, FIVE (5) HANDLES WITH MINI QUICK COUPLING WITH THE PHENOLIC, WOODEN STYLE HANDLES ARE CAUSING BROWN STAINS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8008647 ↗
• MalfunctionOct 26, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, FIVE (5) HANDLES WITH MINI QUICK COUPLING WITH THE PHENOLIC, WOODEN STYLE HANDLES ARE CAUSING BROWN STAINS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8008640 ↗
• MalfunctionOct 26, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, FIVE (5) HANDLES WITH MINI QUICK COUPLING WITH THE PHENOLIC, WOODEN STYLE HANDLES ARE CAUSING BROWN STAINS. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8008627 ↗
• MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SCREW DRIVER WOODEN HANDLES FROM A MODULAR HAND SYSTEM ARE BLEEDING AND LEAVING STAINS ON THE LIDS AND CAUSING A CONCERN. THERE IS NO PATIENT INVOLVED AS THIS IS HAPPENING IN STERILE PROCESSING DEPARTMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6832105 ↗
• MalfunctionAug 30, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SCREW DRIVER WOODEN HANDLES FROM A MODULAR HAND SYSTEM ARE BLEEDING AND LEAVING STAINS ON THE LIDS AND CAUSING A CONCERN. THERE IS NO PATIENT INVOLVED AS THIS IS HAPPENING IN STERILE PROCESSING DEPARTMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6832063 ↗