MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 POLYAXIAL SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48280310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; locking mechanism of the screwdriver defective.Therefore the screw was inserted with high pressure on the screwdriver.Screw loosened and must be replaced during medical procedure.Another screw was available.
Additional Manufacturer Narrative
Lot# 141462.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: upon visual and functional inspection of the returned device, no anomalies were found.The screwdriver was found fully functional.Conclusion: the reported failure mode could not be reproduced or confirmed therefore the root cause cannot be determined conclusively.
Event or Problem Description
It was reported that; locking mechanism of the screwdriver defective.Therefore the screw was inserted with high pressure on the screwdriver.Screw loosened and must be replaced during medical procedure.Another screw was available.

• Brand Name: ES2 POLYAXIAL SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6458251
• Report Number: 0009617544-2017-00125
• Device Sequence Number: 591453
• Product Code: LXH
• UDI-Device Identifier: 04546540710475
• UDI-Public: (01)04546540710475
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

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: 48280310
• Device Lot Number: 141462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR