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

Catalog Number	48231326
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip on the screwdriver for closed head screws sheared off from screwdriver upon insertion of screw into the bone.Screw and tip were left in place and used in construct.The tap was broken in bone upon tapping the bone.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; manufacturing records were reviewed for the corresponding lot and no relevant issues were identified a device with the same failure mode was sent for material analysis and the threaded tip was found to have a ductile overload fracture.The probable root cause of the reported event is most likely user related.
Event or Problem Description
It was reported that the tip on the screwdriver for closed head screws sheared off from screwdriver upon insertion of screw into the bone.Screw and tip were left in place and used in construct.The tap was broken in bone upon tapping the bone.

• 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: 5499063
• Report Number: 0009617544-2016-00117
• Device Sequence Number: 18894477
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2016

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: 48231326
• Device Lot Number: 140957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2016
• Supplement Report FDA Received Date: 10/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 73