MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C SCREWDRIVER - STRAIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48328500
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the screwdriver head broke off in screw head.We could not remove the piece of metal nor the screw so screwdriver head remained in screw in the patient.
Additional Manufacturer Narrative
(b)(6).Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the product was confirmed visually to have its tip fractured.Manufacturing files were reviewed and revealed to be approximately 5 years old with no anomalies found.Rep reported that the instrument has been used over 100 times.Conclusion: the probable root cause is normal wear.
Event or Problem Description
It was reported that: the screwdriver head broke off in screw head.We could not remove the piece of metal nor the screw so screwdriver head remained in screw in the patient.

• Brand Name: ANCHOR C SCREWDRIVER - STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5517418
• Report Number: 0009617544-2016-00130
• Device Sequence Number: 386032
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: (01)07613327267082
• 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): 02/26/2016

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: 48328500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2016
• 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