MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT T15, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703595
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during metal removal, a torx15 screwdriver bit on the torx broke off.Replacement was available.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned and matches the alleged failure.The device inspection revealed the following: hexagonal tip of the received screwdriver found broken, and the broken fragment was not available for investigation.Tip of the available screwdriver shows deformation i.E.The teeth are shifted in one direction due to action of high torsional force resulting in permanent plastic deformation.The shaft-part is twisted, and material scratched against material (¿rubbed shiny¿) leaving a darker area in the middle which is usually a kind of dimple.The breakage was found to be symmetric with no abrupt breakage surface.The fracture surface resembles a typical ductile fracture due to torsional overload.Furthermore, a hardness test according to (b)(4) on the returned item indicates the material being in accordance to the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be a user related issue as the breakage was caused due to torsional overload.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during metal removal, a torx15 screwdriver bit on the torx broke off.Replacement was available.".

• Brand Name: SCREWDRIVER BIT T15, AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18967494
• Report Number: 0008031020-2024-00129
• Device Sequence Number: 20499676
• Product Code: LXH
• UDI-Device Identifier: 04546540694171
• UDI-Public: 04546540694171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 703595
• Device Lot Number: K0D6786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown