MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREWDRIVER ASNIS JFX T20, AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705366
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the cannulated screw driver blade from the asnis jones fracture set broke during screw insertion.There was about a 5 minute surgical delay as the surgeon needed to pick out the broken piece of the screw driver blade that was lodged in the screw head.
Event or Problem Description
It was reported that the cannulated screw driver blade from the asnis jones fracture set broke during screw insertion.There was about a 5 minute surgical delay as the surgeon needed to pick out the broken piece of the screw driver blade that was lodged in the screw head.
Additional Manufacturer Narrative
Correction: sections d4 (lot #), d10, h3, h6 the reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by repeated powerful dynamically overload during use over the years.The device inspection revealed the following: the returned cannulated screwdriver tip is indeed completely broken / snapped off during screw insertion.Close up views, done by the microscope, indicating though that the surface of the breakage is homogenous which again indicate conformity to the given specification.Note that also some cracks are clearly evident whereas the high applied forces led to a strain hardening / embrittlement of the material which finally resulted in the breakage (over time).Note that this screwdriver was manufactured in nov.2016.Therefore we can state that the root cause of the failure was caused due to (repeated) powerful dynamically overload during use over the years.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: CANNULATED SCREWDRIVER ASNIS JFX T20, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8631623
• Report Number: 0008031020-2019-00513
• Device Sequence Number: 1992736
• Product Code: LXH
• UDI-Device Identifier: 07613327172867
• UDI-Public: 07613327172867
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/17/2019

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 Expiration Date: 10/31/2021
• Device Catalogue Number: 705366
• Device Lot Number: V33678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1