MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY 5MM BLOCKER INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48047070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blocker inserter was broken during the surgery.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.Upon inspection it was found that half of the tip fractured off of the device.The fractured piece was not returned.The surgery was successfully completed with a backup instrument.No relevant manufacturing issues were identified for the reported lot #.The plausible root cause of the reported event is most likely too much bending force applied to the inserter tip along with normal wear due to extended use.
Event or Problem Description
It was reported that blocker inserter was broken during the surgery.

• Brand Name: XIA DEFORMITY 5MM BLOCKER INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6196243
• Report Number: 0009617544-2016-00499
• Device Sequence Number: 13498955
• Product Code: LXH
• UDI-Device Identifier: 07613327263398
• UDI-Public: (01)07613327263398
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2017

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: 48047070
• Device Lot Number: 128070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 02/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1