MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, T7, AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	45-27015
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "broken torx t7 blade".
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 tip of the screwdriver is broken off as complained.The device inspection revealed the following: the visual inspection has shown that the tip of the screwdriver is broken off, the fragment was returned for evaluation.The microscopic evaluation has shown that the view of the fracture face is typical for a brittle overload fracture with chevron marks and a shear lip on one side.The shear lip indicates that the device was exposed to high lateral forces when it broke.Based on that it can be concluded that a combination of high torsional and lateral forces during screw extraction did lead to a mechanical overload.The remainder of the tip is twisted in counterclockwise direction.This indicates that most likely during the loosening of a screw a plastic deformation occurred before the device finally broke due to the mechanical overload.Furthermore, a hardness test according to rockwell 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.Based on investigation, the root cause was finally attributed to a user related issue.The failure was caused by applying too much torsional and lateral force which did lead to a mechanical overload during the extraction of a screw.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "broken torx t7 blade".

• Brand Name: SCREWDRIVER BLADE, T7, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18389054
• Report Number: 0008031020-2023-00443
• Device Sequence Number: 17176921
• Product Code: LXH
• UDI-Device Identifier: 04546540540423
• UDI-Public: 04546540540423
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 45-27015
• Device Lot Number: 1000508671
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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 Sex: Unknown