MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX HYBRID REVISION DRIVER SCREW EXTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48511906
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; after surgeon has inserted the screw, and removing the instrument, surgeon noticed that the tip of instrument was damaged and could not be used on another surgery.The procedure was an cervical anterior arthrodesis.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: manufacturing records were reviewed and no issues were found for this lot number.Conclusion: the stryker rep did not respond to any questions and did not return the parts, so the probable root cause is not determined due to lack of parts available.
Event or Problem Description
It was reported that; after surgeon has inserted the screw, and removing the instrument, surgeon noticed that the tip of instrument was damaged and could not be used on another surgery.The procedure was an cervical anterior arthrodesis.

• Brand Name: REFLEX HYBRID REVISION DRIVER SCREW EXTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5677123
• Report Number: 0009617544-2016-00203
• Device Sequence Number: 292812
• Product Code: LXH
• UDI-Device Identifier: 07613327271003
• UDI-Public: (01)07613327271003
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/27/2016

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: 48511906
• Device Lot Number: 137622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2016
• Supplement Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1