MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM ILIAC SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48231326
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It as reported that the screwdriver tip broke upon screw insertion.
Additional Manufacturer Narrative
The customer reported event was confirmed via correspondence.The device was not returned thus visual inspection could not be performed.Manufacturing records were reviewed for the lot and no relevant issues were identified.It was reported that the patient had hard bone quality and high torque was applied to the driver as a result.The fractured tip of the driver was recovered.According to similar material analysis and the event description, the most likely root cause is excessive torque was applied to the driver due to the patient's strong bone quality causing it to fracture.
Event or Problem Description
It as reported that the screwdriver tip broke upon screw insertion.

• Brand Name: XIA 3 TITANIUM ILIAC SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7224302
• Report Number: 0009617544-2018-00024
• Device Sequence Number: 16433701
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/19/2018

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 Model Number: 48231326
• Device Catalogue Number: 48231326
• Device Lot Number: 141256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1