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

Catalog Number	48511906B
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	12/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner draw rod on the revision screw driver brown during a 2 level hwr with adjacent lvl acdf.The distal tip of the driver broke off.Other screwdriver was used and everything came out fine.No additional time was added to the case.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; no manufacturing issues were found for this lot number.Device was not returned.The cause is not determined and multifactorial due to no instrument returned.
Event or Problem Description
It was reported that the inner draw rod on the revision screw driver brown during a 2 level hwr with adjacent lvl acdf.The distal tip of the driver broke off.Other screwdriver was used and everything came out fine.No additional time was added to the case.

• Brand Name: REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR
• Common Device Name: OPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6234198
• Report Number: 0009617544-2017-00007
• Device Sequence Number: 1477284
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: (01)07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 14A804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1