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

Model Number	48511906B
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; acdf removal of plate.Update (b)(6) 2017: during a routine plate removal.Patient fused well but was addressing the adjacent level for an acdf.Bone had imbedded in screw head.Tip of instrument broke.All broken fragments retrieved.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: visual inspection, the draw rod was confirmed broken at the distal tip.No manufacturing issues were discovered and the device was found to be in the field for 7 years.Conclusion: due to the instrument age, the probable root cause is normal wear.
Event or Problem Description
It was reported that; acdf removal of plate.Update 11/15/2017: during a routine plate removal.Patient fused well but was addressing the adjacent level for an acdf.Bone had imbedded in screw head.Tip of instrument broke.All broken fragments retrieved.

• 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: 7040355
• Report Number: 0009617544-2017-00412
• Device Sequence Number: 1159099
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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 Model Number: 48511906B
• Device Catalogue Number: 48511906B
• Device Lot Number: 109522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1