MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER T20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	703539
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
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
Screwdriver was being used to back out a screw and the tip broke off.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received screwdriver shows normal signs of usage however its tip is found to be broken.The broken tip was not received for evaluation.The breakage surface in the shaft shows rotational deformation in a counterclockwise direction.The flutes appear slightly twisted as well.This is a typical ductile overload fracture due torsional overload while backing out the screw.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.The above investigation has determined the failure mode and a corrective action report was opened in order to address the issue of increasing reports regarding breakages of the blade of ¿screwdriver t20¿ with cat # 703539.As a result, a capa was opened as an opportunity to improve the design of the screwdriver blade.A design change was implemented to address these breakages: the blade of the screwdriver was shortened in order to increase its strength and consequently reduce the amount of breakages.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.The breakage of the tip happened due to a torsional overload.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Screwdriver was being used to back out a screw and the tip broke off.

• Brand Name: SCREWDRIVER T20
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9765363
• Report Number: 0008031020-2020-00521
• Device Sequence Number: 13631844
• Product Code: LXH
• UDI-Device Identifier: 04546540693778
• UDI-Public: 04546540693778
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 703539
• Device Catalogue Number: 703539
• Device Lot Number: K621098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1