MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER, SELF-HOLDING, SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0238
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
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
The tip of the screwdriver broke.It was noticed during instrument preparation.
Event or Problem Description
The tip of the screwdriver broke.It was noticed during instrument preparation.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned screwdriver with self-holding feature shows normal traces of use.The breakage surface shows the typical structure of a forced brittle fracture which indicated through the river lines; no plastic deformation, especially along the edge of the breakage surface was found.The appearance of the breakage surface indicates a (forced) brittle breakage of the screw driver due to overload, most likely by bending stresses.A review of the labeling did not indicate any abnormalities.Based on the investigation performed the root cause of the reported event is related to inadequate handling by the user.If any further information is provided, the complaint report will be updated.

• Brand Name: SCREWDRIVER, SELF-HOLDING, SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM
• 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: 9441239
• Report Number: 0009610622-2019-00959
• Device Sequence Number: 14300151
• Product Code: LXH
• UDI-Device Identifier: 04546540520432
• UDI-Public: 04546540520432
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 1806-0238
• Device Catalogue Number: 18060238
• Device Lot Number: KMW351102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1