MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM UNIVERSAL TIGHTENER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48237008
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device fractured during a procedure.No delay and no adverse consequences.
Additional Manufacturer Narrative
Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The surgical technique clearly mentions that the tightener should not be used for final tightening.The event occured during final tightening implying deviation from operating technique.Conclusion: the most likely cause of the reported event was determined to be deviation from surgical protocol.
Event or Problem Description
It was reported that the device fractured during a procedure.No delay and no adverse consequences.

• Brand Name: XIA 3 TITANIUM UNIVERSAL TIGHTENER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5753069
• Report Number: 0009617544-2016-00254
• Device Sequence Number: 13592355
• Product Code: LXH
• UDI-Device Identifier: 07613327265330
• UDI-Public: (01)07613327265330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2016

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: 48237008
• Device Lot Number: 133488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2016
• Supplement Report FDA Received Date: 09/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1