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

Model Number	48328500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screwdriver tip broke and stuck in screw head.
Additional Manufacturer Narrative
Lot# 166113.Device history review, complaint history review, risk assessment.Device history review was performed and all released units met stryker specification.The plausible root cause of the screwdriver fracture cannot be identified conclusively.
Event or Problem Description
It was reported that; screwdriver tip broke and stuck in screw head.

• 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: 6553971
• Report Number: 0009617544-2017-00193
• Device Sequence Number: 19033300
• Product Code: LXH
• UDI-Device Identifier: 07613327267082
• UDI-Public: (01)07613327267082
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: 48328500
• Device Catalogue Number: 48328500
• Device Lot Number: 166113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR