MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48510810
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a final tightener broke off.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: manufacturing files were reviewed and no manufacturing issues were found for this lot number.The instrument was reported to have been used at least times per week.Manufacturing review revealed that the instrument was manufactured and released in 2011.Conclusion: the likely root cause normal wear of the instrument.
Event or Problem Description
It was reported that the tip of a final tightener broke off.

• Brand Name: REFLEX-HYBRID FINAL-TIGHTENING SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5606387
• Report Number: 0009617544-2016-00162
• Device Sequence Number: 13481468
• Product Code: LXH
• UDI-Device Identifier: 07613327270921
• UDI-Public: (01)07613327270921
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2016

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: 48510810
• Device Lot Number: 115855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2016
• Supplement Report FDA Received Date: 06/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention