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 Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; 5.5 mm tap broke during surgery.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.
Event or Problem Description
It was reported that; 5.5 mm tap broke during surgery.

• 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: 6104712
• Report Number: 0009617544-2016-00453
• Device Sequence Number: 893995
• Product Code: LXH
• UDI-Device Identifier: 07613327264883
• UDI-Public: (01)07613327264883
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2017

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 Catalogue Number: 48230055
• Device Lot Number: 126832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 113