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

Catalog Number	48231326
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: surgeon was using screwdriver and stripped the threads on the driver rendering it useless, rep was able to solve the problem by utilizing secondary backup to which was broken as well (this surgeon breaks these about every two weeks) the replacement device used was the backup and the screws were not left damaged and the case was able to close unimpeded.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Ifu for instruments states that the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.The age of the device was found to be almost a year however it is unknown how many times the device has been used.Conclusion: the probable root causes of this event is multifactorial and not determined due to insufficient information provided.
Event or Problem Description
It was reported: surgeon was using screwdriver and stripped the threads on the driver rendering it useless, rep was able to solve the problem by utilizing secondary backup to which was broken as well (this surgeon breaks these about every two weeks) the replacement device used was the backup and the screws were not left damaged and the case was able to close unimpeded.

• 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: 5749017
• Report Number: 0009617544-2016-00250
• Device Sequence Number: 16687
• Product Code: LXH
• UDI-Device Identifier: 07613327265279
• UDI-Public: (01)07613327265279
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2016

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: 141253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2016
• Supplement Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1