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

Model Number	48230055
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	07/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that modular tap broke during screwing in into the vertebral body.Replacement was available.
Additional Manufacturer Narrative
Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The visual inspection of the device showed that the tap was returned in 2 pieces.The device has been in the field for around 7 years.The root cause of the event was determined to be fatigue fracture due to normal wear of the device from multiple use.
Event or Problem Description
It is reported that modular tap broke during screwing in into the vertebral body.Replacement was available.

• 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: 6786685
• Report Number: 0009617544-2017-00314
• Device Sequence Number: 604425
• Product Code: LXH
• UDI-Device Identifier: 07613327264883
• UDI-Public: (01)07613327264883
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 48230055
• Device Catalogue Number: 48230055
• Device Lot Number: 09D95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1