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	02/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the pedicle marker broke at left side l5 when the surgeon was inserting the marker into the pedicle.The surgeon tilted the holder to distal during the insertion.After that, the broken part was removed.The surgeon used the other marker and continued the surgery.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met stryker specifications.The device was inspected and it was found that it was fractured into two pieces.The definite root cause could not be determined conclusively.
Event or Problem Description
It was reported that; during surgery, the pedicle marker broke at left side l5 when the surgeon was inserting the marker into the pedicle.The surgeon tilted the holder to distal during the insertion.After that, the broken part was removed.The surgeon used the other marker and continued the surgery.

• 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: 6410834
• Report Number: 0009617544-2017-00097
• Device Sequence Number: 10928488
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 10G520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR