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

Catalog Number	48511906
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the top of the screw extractor was broken during surgery.
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assesment; result: the device tip was reported to have fractured.Manufacturing records were reviewed and no issues were found for this lot number.The device was found to be in the field for approximately 4 years.Conclusion: considering the number of uses reported, the instrument age and finally the use of this instrument with non-stryker devices, the root causes of the reported event are likely a combination of user misuse and normal wear.
Event or Problem Description
It was reported that the top of the screw extractor was broken during surgery.

• Brand Name: REFLEX HYBRID REVISION DRIVER 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: 5692855
• Report Number: 0009617544-2016-00215
• Device Sequence Number: 1560
• Product Code: LXH
• UDI-Device Identifier: 07613327271003
• UDI-Public: (01)07613327271003
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 05/09/2016

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: 48511906
• Device Lot Number: 122729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2016
• Supplement Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1