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	04/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; noticed a broken tap and loose hinged rod holder.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment.Visual, dimensional and functional analysis could not be performed as the device was not returned and lot was not provided.The definitive root cause of the event could not be determined from given information.
Event or Problem Description
It was reported that; noticed a broken tap and loose hinged rod holder.

• 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: 6530470
• Report Number: 0009617544-2017-00180
• Device Sequence Number: 1033357
• 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): 07/20/2017

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: 04/03/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1