MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT, LONG IMN INSTRUMENTS 3.5MM

Catalog Number	23510110
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when removing the als, the screws were hard and the screw heads were worn, so the screws were removed using the self-retaining screwdriver sleeves.The screw and self-retaining screwdriver sleeve are no longer detached.During same surgery, two screwdriver bits were damaged but it is not known under what circumstances they were damaged.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The received screwdriver bit, long was visually inspected, and we can see that the across corner region of the hex is damaged it is deformed with a material line to the right side from the across line which indicates excessive force application while the screw extraction.This is visible in the locking screw head where we can see misalignment with the head and application of excessive force.It was also seen that left-handed helix threads are also flattened which is feasible from holding it with high force.Further, the dimensional analysis was conducted and the device was within the 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 the above investigation the root cause can be attributed to user-related that the deformation of the hex was caused by the application of excessive force.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when removing the als, the screws were hard and the screw heads were worn, so the screws were removed using the self-retaining screwdriver sleeves.The screw and self-retaining screwdriver sleeve are no longer detached.During same surgery, two screwdriver bits were damaged but it is not known under what circumstances they were damaged.".

• Brand Name: SCREWDRIVER BIT, LONG IMN INSTRUMENTS 3.5MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18419810
• Report Number: 0009610622-2023-00466
• Device Sequence Number: 12450450
• Product Code: HXX
• UDI-Device Identifier: 07613327376463
• UDI-Public: 07613327376463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/20/2024

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: 23510110
• Device Lot Number: KP491457
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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 Age: 18 YR
• Patient Sex: Male