MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 PEDICLE MARKERS (SET OF 6); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48237081
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	12/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery, the tip of the marker broke.The broken tip was removed from the patient.The bone quality was hard and the surgeon hit the marker into the bone by the hammer.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: tip fracture was confirmed via visual inspection.No relevant manufacturing issues were identified as all units met specifications conclusion: a definite root cause could not be determined conclusively.
Event or Problem Description
It was reported that during a surgery, the tip of the marker broke.The broken tip was removed from the patient.The bone quality was hard and the surgeon hit the marker into the bone by the hammer.

• Brand Name: XIA 3 PEDICLE MARKERS (SET OF 6)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6267855
• Report Number: 0009617544-2017-00018
• Device Sequence Number: 10816012
• Product Code: LXH
• UDI-Device Identifier: 07613327265590
• UDI-Public: (01)07613327265590
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: 48237081
• Device Lot Number: 10G518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR