MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48511905R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ater final x-rays on a 3-level acdf (c3-6) it was determined one level of screws was not in vertebral body but in disc space.The surgeon was comfortable that removing screws and not replacing would not compromise fusion.The 3-piece screw extractor tool was assembled and used.First screw was removed.Upon attempt of second screw removal the tip of the inner shaft screw extractor sheared off within the cruciform of the bone screw.The surgeon attempted to remove with other tools but because the shaft was in the cruciform he decided to leave it in as it posed no compromise to fusion or instrumentation.
Additional Manufacturer Narrative
The device was confirmed visually to have a fractured tip.Manufacturing files were reviewed and no anomalies were found.Manufacturing review revealed a part that was approximately seven years old.The probable root cause is normal wear.
Event or Problem Description
It was reported that ater final x-rays on a 3-level acdf (c3-6) it was determined one level of screws was not in vertebral body but in disc space.The surgeon was comfortable that removing screws and not replacing would not compromise fusion.The 3-piece screw extractor tool was assembled and used.First screw was removed.Upon attempt of second screw removal the tip of the inner shaft screw extractor sheared off within the cruciform of the bone screw.The surgeon attempted to remove with other tools but because the shaft was in the cruciform he decided to leave it in as it posed no compromise to fusion or instrumentation.

• Brand Name: REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5945712
• Report Number: 0009617544-2016-00363
• Device Sequence Number: 93569
• Product Code: LXH
• UDI-Device Identifier: 07613327276831
• UDI-Public: (01)07613327276831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2016

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: 48511905R
• Device Lot Number: 09C665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR