MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, AO, T6, SELF-RETAIN.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705132
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: the t6 screwdriver blades are bending/ warping during surgery.One of the t6 screwdriver blade tips snapped off completely.
Additional Manufacturer Narrative
The reported event could be confirmed, only based on the pictures received.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: the t6 screwdriver blades are bending/ warping during surgery.One of the t6 screwdriver blade tips snapped off completely.

• Brand Name: SCREWDRIVER BLADE, AO, T6, SELF-RETAIN.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10200700
• Report Number: 0008031020-2020-01777
• Device Sequence Number: 2865412
• Product Code: LXH
• UDI-Device Identifier: 07613327398915
• UDI-Public: 07613327398915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/30/2020

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 Model Number: 705132
• Device Catalogue Number: 705132
• Device Lot Number: 1000382962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1