MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX HYBRID QUICK TURN INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48511820B
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	02/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the draw rod (head) has failed.
Additional Manufacturer Narrative
Lot# 09c120; visual inspection; device history review; complaint history review; risk assessment.The tip was confirmed fractured.Manufacturing files were reviewed and no anomalies were found.Manufacturing review revealed an instrument approximately 7 years old.The probable root cause is normal wear based on usage and instrument age.
Event or Problem Description
It was reported that the draw rod (head) has failed.

• Brand Name: REFLEX HYBRID QUICK TURN INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6425472
• Report Number: 0009617544-2017-00109
• Device Sequence Number: 551278
• Product Code: LXH
• UDI-Device Identifier: 07613327277012
• UDI-Public: (01)07613327277012
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/24/2017

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: 48511820B
• Device Lot Number: 09C120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1