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

Catalog Number	48237008
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a universal tightener was broken at scoliosis correction level to rod during the surgery.The surgery was completed successfully with the spare device.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no discrepancies or anomalies were identified.Tip fracture was confirmed via visual inspection of the returned device.The most likely causes of the reported event based on previous similar complaints are: overload of the driver tip and normal wear of the device.
Event or Problem Description
It was reported that a universal tightener was broken at scoliosis correction level to rod during the surgery.The surgery was completed successfully with the spare device.

• 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: 6251699
• Report Number: 0009617544-2017-00009
• Device Sequence Number: 16163721
• Product Code: LXH
• UDI-Device Identifier: 07613327265330
• UDI-Public: (01)07613327265330
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2017

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: 126838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1