MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, T10, AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	45-35015
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
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 when the variax clavicle was removed at (b)(6) 2019 because the bone fusion was confirmed.When the screw was tried to removed with driver (45-35015), it was broken.A spare driver was not prepared and the operation was interrupted for about 30 min to arrange for a new driver.After that, the operation was finished and the adverse event due to this event not occurred.
Additional Manufacturer Narrative
The reported event was confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by repeated powerful dynamically overload during use.The device inspection revealed the following: the tip of the returned screwdriver blade is indeed completely broken / snapped off during the screw removal attempt.A close up of the fracture surface shows some cracks, whereas the high applied forces led to a strain hardening / embrittlement of the material which finally resulted in the breakage (over time).The characteristics indicate a typically torsional overload breakage.The t10 drive is still in good condition though, which clearly indicates that the screw may have been stuck and the applied force finally caused the breakage of the tip.The root cause of the failure was repeated powerful dynamically overload during use.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.
Event or Problem Description
It was reported that when the variax clavicle was removed at(b)(6)2019 because the bone fusion was confirmed.When the screw was tried to removed with driver (45-35015), it was broken.A spare driver was not prepared and the operation was interrupted for about 30 min to arrange for a new driver.After that, the operation was finished and the adverse event due to this event not occurred.

• Brand Name: SCREWDRIVER BLADE, T10, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8374924
• Report Number: 0008031020-2019-00136
• Device Sequence Number: 2205430
• Product Code: LXH
• UDI-Device Identifier: 04546540540461
• UDI-Public: 04546540540461
• 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): 04/11/2019

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: 45-35015
• Device Lot Number: AE08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR