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 Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor had an acdf revision and was removing the plate (nothing wrong with the plate), and the threaded portion of the draw rod (48511906b)broke off into the screwhead during removal.He was able to get the screws and plate out successsfully after that but the tip of the inner shaft broke off.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the screw extractor was confirmed visually to have a fractured tip.Manufacturing records were reviewed and no issues were found for this lot number.The instrument has been in the field for approximately 4 years.Conclusion: the probable root cause is normal wear.
Event or Problem Description
It was reported that the doctor had an acdf revision and was removing the plate (nothing wrong with the plate), and the threaded portion of the draw rod (48511906b)broke off into the screwhead during removal.He was able to get the screws and plate out successfully after that but the tip of the inner shaft broke off.

• 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: 6305632
• Report Number: 0009617544-2017-00049
• Device Sequence Number: 19062306
• Product Code: LXH
• UDI-Device Identifier: 07613327276855
• UDI-Public: (01)07613327276855
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 04/18/2017

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: 12C218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR