MAUDE Adverse Event Report: STRYKER SPINE-US POLYAXIAL SCREWDRIVER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48268011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screwdriver broke in half while inserting a screw.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection of the returned device.Material analysis was performed on the device.The shaft was found to have fractured in a mixed mode of cleavage and ductile due to an applied bending load.The hardness and elemental constituents were consistent with specifications.No material or manufacturing defects were found.Based on the material analysis, the most likely root cause is bending load applied to the driver during screw insertion.The surgical technique guide also recommends tapping for most cases, and the lack of tapping during screw hole preparation may have also contributed to the event by requiring the surgeon to use more force to place the screw into the prepared hole.
Event or Problem Description
It was reported that a screwdriver broke in half while inserting a screw.No adverse consequences to the patient were reported.

• Brand Name: POLYAXIAL SCREWDRIVER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7694463
• Report Number: 0009617544-2018-00176
• Device Sequence Number: 1511025
• Product Code: LXH
• UDI-Device Identifier: 07613327356656
• UDI-Public: 07613327356656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/26/2018

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: No Information
• Device Catalogue Number: 48268011
• Device Lot Number: 17A964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1