MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER STRIKE PLATE GAMMA3® 8X250MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
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
The snap ring on the thread is broken.The screwdriver can no longer be screwed in.The breakage was observed after the procedure.
Event or Problem Description
The snap ring on the thread is broken.The screwdriver can no longer be screwed in.The breakage was observed after the procedure.
Additional Manufacturer Narrative
The reported event could be confirmed.A review of the inspection records revealed no discrepancies.The device inspection revealed the following: a screwdriver strike plate gamma3® 8x250mm for evaluation with a completely missing c-ring.As nothing was reported during last functional check before the last usage and due to the fact it was ¿observed after the procedure¿ the case [damaged/detached c-ring] is rather related to a sub-optimal intraoperative procedure [inadequate handling].Due to missing check of the c-ring, it was not recognized that it was damaged [broken].Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to inadequate handling and has to be classified as user related.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.If any further information is provided, the investigation report will be updated.

• Brand Name: SCREWDRIVER STRIKE PLATE GAMMA3® 8X250MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9766460
• Report Number: 0009610622-2020-00079
• Device Sequence Number: 19460971
• Product Code: LXH
• UDI-Device Identifier: 04546540377647
• UDI-Public: 04546540377647
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: 1320-0070
• Device Catalogue Number: 13200070
• Device Lot Number: K398678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1