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

Catalog Number	48511906B
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "adjacent level surgery was being performed (anterior cervical), we we're removing old plate to fit new plate at new diseased level.While using the removal driver, the inner-rod tip broke off in the screw head.Caused a 45 second delay while the screw was removed the rest of the way with a regular driver.It did not affect patient or outcome, and the broken piece was not retrieved due to hardware being returned to patient post case.It's been used maybe 100 times and has been used successfully in the past.".
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed and no issues were found for this lot number.The screw extractor was confirmed visually to have a fractured tip.The instrument was reported to have been used 100 times and was found to be approximately 3 years old.The probable root cause is normal wear.
Event or Problem Description
It was reported that "adjacent level surgery was being performed (anterior cervical), we we're removing old plate to fit new plate at new diseased level.While using the removal driver, the inner-rod tip broke off in the screw head.Caused a 45 second delay while the screw was removed the rest of the way with a regular driver.It did not affect patient or outcome, and the broken piece was not retrieved due to hardware being returned to patient post case.It's been used maybe 100 times and has been used successfully in the past.".

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD 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: 6326958
• Report Number: 0009617544-2017-00057
• Device Sequence Number: 19223442
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: (01)07613327276855
• 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): 04/21/2017

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: 48511906B
• Device Lot Number: 137624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1