MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM IN SITU ROD BENDER RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48237011R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; point of in-situ rod bender broke off.Replacement was not necessary and the case was not delayed.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.The device was confirmed to have the tip deformed during implantation.Manufacturing files were reviewed and no anomalies were found.The instrument was found to be approximately 11 years old.The probable root cause is normal wear based on the age of the instrument.
Event or Problem Description
It was reported that; point of in-situ rod bender broke off.Replacement was not necessary and the case was not delayed.

• Brand Name: XIA 3 TITANIUM IN SITU ROD BENDER RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5964927
• Report Number: 0009617544-2016-00368
• Device Sequence Number: 85101
• Product Code: LXH
• UDI-Device Identifier: 07613327276633
• UDI-Public: (01)07613327276633
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/26/2016

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: 48237011R
• Device Lot Number: 071225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1