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); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned to manufacturer.
Event or Problem Description
It was reported that the pedicle marker was pushed into the patient broke.The marker was successfully removed from the patient and there was no intervention or adverse consequences.There was a 10-15 minute delay.The representative present during the case was informed that the staff disposed of the marker.
Additional Manufacturer Narrative
Method: labelling review, risk assessment result:the customer reported event was confirmed via photos provided by the rep.The device was disposed at hospital and lot number was not provided, therefore a manufacturing record review could not be performed.Conclusion: as the device was not returned and additional information was not provided, a definite root cause cannot be determined.Possible root causes include excessive insertion force, hard bone quality, age of the device, difficult insertion angle, improper instrument used, inadequate screw hole preparation, and/or application of cantilever forces.
Event or Problem Description
It was reported that the pedicle marker was pushed into the patient broke.The marker was successfully removed from the patient and there was no intervention or adverse consequences.There was a 10-15 minute delay.The representative present during the case was informed that the staff disposed of the marker.

• 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: 7796853
• Report Number: 0009617544-2018-00200
• Device Sequence Number: 16511169
• Product Code: LXH
• UDI-Device Identifier: 07613327265590
• UDI-Public: 07613327265590
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1