MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM ILIAC SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48231326
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; while implanting 8.5x80 screw w thandle attached to screwdriver.Got 3/4 way in and head snapped/broke resulting in breaking the head of screw.Head of screw was retrieved from patient.
Additional Manufacturer Narrative
No relevant manufacturing issues were identified as all units met specifications.The screwdriver tip was confirmed to be fractured.The plausible root cause of the issue was determined to be over torquing of the driver along with improper preparation of the screw hole.
Event or Problem Description
It was reported that; while implanting 8.5x80 screw w thandle attached to screwdriver.Got 3/4 way in and head snapped/broke resulting in breaking the head of screw.Head of screw was retrieved from patient.

• Brand Name: XIA 3 TITANIUM ILIAC 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: 6681581
• Report Number: 0009617544-2017-00275
• Device Sequence Number: 101334
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2017

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 Model Number: 48231326
• Device Catalogue Number: 48231326
• Device Lot Number: 140956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1