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

Catalog Number	48237081
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Pedicle marker broke when removing the marker, and a part of the broken marker pin remained in the body.Procedure was completed successfully.No adverse consequences were reported.
Event or Problem Description
Pedicle marker broke when removing the marker, and a part of the broken marker pin remained in the body.Procedure was completed successfully.No adverse consequences were reported.
Additional Manufacturer Narrative
Method: product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via correspondence with the rep.All broken pieces were retrieved.The marker was discarded at the hospital, so inspection could not be performed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was manufactured in 2010.It was also reported that the surgeon appeared to apply some excessive force to the instrument and also applied force inward.It was determined that the device was 8 years old at the time of the event.The ifu states "the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order." conclusion: the most likely root cause of the event is a combination of excessive bending force with the age of the device.Device was discarded at hospital.

• Brand Name: XIA 3 PEDICLE MARKERS (SET OF 6)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8168846
• Report Number: 0009617544-2018-00297
• Device Sequence Number: 1684213
• Product Code: LXH
• UDI-Device Identifier: 07613327265590
• UDI-Public: 07613327265590
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1