MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM MODULAR TAP DIAM 5.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48230055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tap broke while tapping pedicle.
Additional Manufacturer Narrative
Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection of the device showed that the tip of the tap fractured at the uppermost laser marking.Wear markings were present on the tap, such as scratches and gouging.The device has been in the market for approximately 7 years and the frequency of use of the device is 2 times a week.The ifu for instruments states " 1.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.2.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery " conclusion: the most likely cause of the fracture is that the instrument was not properly examined for wear prior to sugery and fractured during surgery due to normal wear.
Event or Problem Description
It was reported that the tap broke while tapping pedicle.

• Brand Name: XIA 3 TITANIUM MODULAR TAP DIAM 5.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5945556
• Report Number: 0009617544-2016-00362
• Device Sequence Number: 1917109
• Product Code: LXH
• UDI-Device Identifier: 07613327264883
• UDI-Public: (01)07613327264883
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2016

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: 48230055
• Device Lot Number: 09A346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1