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

Catalog Number	48231326
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the second revision surgery was performed due to the rod breakage.The left and right of the rod were broke in two levels (left: l4/5 and l3/4, right: l5/s1 and l4/5).During the revision surgery, the surgeon tried to remove the closed polyaxial screw on left s2ai.But the screw was not able to removed and the tip of the drivers was deformed.The screw shaft was remained.This event is related to (b)(4).
Additional Manufacturer Narrative
Method: visual analysis, device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The visual inspection of the driver showed that the tip of the screwdriver was deformed.The tip was bent at the shaft below the threaded section.Conclusion: the probable root cause is that the surgeon applied a excessive torsional force at a slight incline that caused the screwdriver tip to deform.
Event or Problem Description
It was reported that; the second revision surgery was performed due to the rod breakage.The left and right of the rod were broke in two levels (left : l4/5 and l3/4, right : l5/s1 and l4/5).During the revision surgery, the surgeon tried to remove the closed polyaxial screw on left s2ai.But the screw was not able to removed and the tip of the drivers was deformed.The screw shaft was remained.This event is related to (b)(4).

• 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: 5769993
• Report Number: 0009617544-2016-00272
• Device Sequence Number: 18846225
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2016

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: 120638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2016
• Supplement Report FDA Received Date: 10/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR