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

Catalog Number	45-27015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, during the procedure, the tip of the driver was broken.
Event or Problem Description
It was reported that, during the procedure, the tip of the driver was broken.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Based on investigation, the root cause was attributed to be user related.The failure was caused by the normal wear of the device.The breakage reported can be confirmed.The tip of the device is broken and signs of damage are evident, color fading as well as rust are noticed.The microscope inspection, regarding the screwdriver showed a shinny fracture surface, a sign that the two parts rubbed against each other.The fracture was initiated and had spread over time until the final crack.The device was released in 2012, and has been fulfilling its task since, which lead to its normal wear.Based on the above-mentioned observations, the case could be classified as user-related.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 any further information is provided, the investigation report will be updated.

• Brand Name: SCREWDRIVER BLADE, T7, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8579886
• Report Number: 0008031020-2019-00393
• Device Sequence Number: 2346724
• Product Code: LXH
• UDI-Device Identifier: 04546540540423
• UDI-Public: 04546540540423
• Combination Product (Y/N): N
• 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): 06/14/2019

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: AC05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1