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	02/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; dr was tightening blocker to rod via tulip of screw when the tip of the blocker inserter 'gave way'.Broken tip of inserter was retrieved, but not kept unfortunately - thrown away on accident.The inserter was used 1000's of times successfully.Case was completed successfully without delay or impact to patient.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met stryker specifications.Device was manufactured in 2008.The most likely root cause is a combination of normal wear and excessive force applied to the instrument.
Event or Problem Description
It was reported that; dr was tightening blocker to rod via tulip of screw when the tip of the blocker inserter 'gave way'.Broken tip of inserter was retrieved, but not kept unfortunately - thrown away on accident.The inserter was used 1000's of times successfully.Case was completed successfully without delay or impact to patient.

• 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: 6384169
• Report Number: 0009617544-2017-00070
• Device Sequence Number: 16152760
• Product Code: LXH
• UDI-Device Identifier: 07613327265330
• UDI-Public: (01)07613327265330
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/18/2017

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: 08C772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1