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

Model Number	1806-0203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2020
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
Primary procedure, left gamma long nail.It was reported that the threads of the driver broke when tightening the 5mm screw.The long driver from the set was used to complete the surgery successfully with a delay of less than 1 minute.
Event or Problem Description
Primary procedure, left gamma long nail.It was reported that the threads of the driver broke when tightening the 5mm screw.The long driver from the set was used to complete the surgery successfully with a delay of less than 1 minute.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the reported failure.The device inspection revealed the following: the returned screwdriver with the self-holding feature shows normal traces of use.The device was received with the assembled condition and we can disassemble and assemble easily.The received sleeve shows normal traces of usage and any further visual damage was not found.The breakage surface shows the typical structure of a brittle fracture, due to a bending overload.To prevent the bending, the device is laser-marked with the printing ¿do not lever¿.The appearance of the breakage shows that during screw insertion high bending forces were applied.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The appearance of the breakage surface indicates a (forced) brittle breakage of the screw driver due to overload, most likely by bending stresses where it is clearly mentioned that ¿do not lever¿.A review of the labeling did not indicate any abnormalities.Based on the above facts 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, EXTRA 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: 9656068
• Report Number: 0009610622-2020-00036
• Device Sequence Number: 2361893
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: 04546540520418
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 03/31/2020

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: 1806-0203
• Device Catalogue Number: 18060203
• Device Lot Number: KMW351102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 01/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR