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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
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
It was reported, that two screwdriver bits for axsos3 5mm was broken when attempting to remove a screw from a plate implanted in a patient.
Event or Problem Description
It was reported, that two screwdriver bits for axsos3 5mm was broken when attempting to remove a screw from a plate implanted in a patient.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: both tips of the returned screwdriver blades are completely broken / snapped off.The entire drive (on both screwdrivers) is broken off which indicates that a huge force had been used during this screw removal attempt.Further investigations using the microscope revealed some torsion lines (cracks) which can be noticed, whereas the high applied forces led to a strain hardening / embrittlement of the material which finally resulted in the breakage.The root cause of the failure was repeated powerful dynamically overload during use especially when removing screws.Furthermore, the event details state that the screwdriver has been used to extract a screw out.This device has not been designed to be used during extraction, since the forces applied to it during this step are heightened because of the osteointegration of screws to the bone.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 investigation, the root cause was attributed to be user related.If any further information is provided, the investigation report will be updated.

• 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: 9667992
• Report Number: 0008031020-2020-00269
• Device Sequence Number: 2884474
• Product Code: LXH
• UDI-Device Identifier: 04546540693778
• UDI-Public: 04546540693778
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: K066E5B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1