MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C SCREW EXTRACTOR DRAW ROD REPLACEMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48328625
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon attempted to use the screw extractor.The tip of the screw extractor draw rod broke/bent.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.Deformation was found on the tip of the instrument.A root cause of the event is too much torsional force applied to the instrument leading to deformation.
Event or Problem Description
It was reported that; the surgeon attempted to use the screw extractor.The tip of the screw extractor draw rod broke/bent.

• Brand Name: ANCHOR C SCREW EXTRACTOR DRAW ROD REPLACEMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6798948
• Report Number: 0009617544-2017-00320
• Device Sequence Number: 16452980
• Product Code: LXH
• UDI-Device Identifier: 07613327267181
• UDI-Public: (01)07613327267181
• 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): 10/13/2017

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 Model Number: 48328625
• Device Catalogue Number: 48328625AR
• Device Lot Number: 158493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 56