MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO PEDICULAR SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48905022
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	02/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon accidentally grabbed the screwdriver instead of the solid 3.5mm hex head to remove a screw and the collet tip broke off into the screw.The broken pieces were removed successfully and there was no consequences to the patient.The surgery was not delayed because the sales rep had the surgical tech hand him the correct driver.The procedure was completed successfully.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: a similar device was sent for a material analysis, which determined that the device failed through bidirectional bending and torsional overload in ductile mode with multiple fracture origins.Conclusion: the most likely cause of the reported event is user error: use of wrong instrument as well as the age of the device.
Event or Problem Description
It was reported that the surgeon accidentally grabbed the screwdriver instead of the solid 3.5mm hex head to remove a screw and the collet tip broke off into the screw.The broken pieces were removed successfully and there was no consequences to the patient.The surgery was not delayed because the sales rep had the surgical tech hand him the correct driver.The procedure was completed successfully.

• Brand Name: TRIO PEDICULAR 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: 5489938
• Report Number: 0009617544-2016-00109
• Device Sequence Number: 16242213
• Product Code: LXH
• UDI-Device Identifier: 07613327273144
• UDI-Public: (01)07613327273144
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/12/2016

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: 48905022
• Device Lot Number: 138230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79