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

Catalog Number	48511906
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during anterior cervical arthrodesis procedure (3 levels), the surgeon used the screwdriver to insert the screw and it broke.The surgeon used another screwdriver to finish the procedure.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: materials analysis previously performed found that "the cruciforms of the submitted screw extractors were found to have fractured in a ductile overload mode resulting from the torsional force applied to the screwdriver.The submitted parts conformed with the material and hardness specified on the print.No material or manufacturing defects were found.Conclusion: the possible root cause of this event is multifactorial.
Event or Problem Description
It was reported that; during anterior cervical arthrodesis procedure (3 levels), the surgeon used the screwdriver to insert the screw and it broke.The surgeon used another screwdriver to finish the procedure.

• 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: 5994930
• Report Number: 0009617544-2016-00395
• Device Sequence Number: 13580679
• Product Code: LXH
• UDI-Device Identifier: 07613327271003
• UDI-Public: (01)07613327271003
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/08/2016

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: 126906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2016
• Supplement Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1