MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II UNIVERSAL TIGHTENER 5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03807008
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the set screw was tightened with universal tightener, the tip of the tightener was broken.Therefore, it was changed to a new one and the set screw was tightened.
Additional Manufacturer Narrative
The most likely root cause is wear due to the device's extended use.Excessive torsional force or off axis loading could have also contributed to the event as well.
Event or Problem Description
It was reported that; the set screw was tightened with universal tightener, the tip of the tightener was broken.Therefore, it was changed to a new one and the set screw was tightened.There was no surgical delay or adverse health consequences due to the event.

• Brand Name: XIA II UNIVERSAL TIGHTENER 5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7180047
• Report Number: 0009617544-2018-00003
• Device Sequence Number: 957104
• Product Code: LXH
• UDI-Device Identifier: 07613327262452
• UDI-Public: (01)07613327262452
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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: 03807008
• Device Catalogue Number: 03807008
• Device Lot Number: 114876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1