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	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The pedicle marker that was inserted at s1 level (left) broke when inserting the l5 left screw.Surgeon removed the broken marker, continued the operation, implanted all the screws and finished the operation successfully.All broken fragments were retrieved and no adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via visual inspection.Visually, the fracture surface shows signs consistent of reverse bending.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was manufactured in 2010.Conclusion: the fracture is consistent with reverse bending, so it is possible that the marker was bent while the adjacent screw was being implanted and eventually fractured, possibly the screwdriver contacting the marker or another instrument.The device was also found to be 8 years old, and wear of the device due to its extended use may have also contributed to the event.
Event or Problem Description
The pedicle marker that was inserted at s1 level (left) broke when inserting the l5 left screw.Surgeon removed the broken marker, continued the operation, implanted all the screws and finished the operation successfully.All broken fragments were retrieved and no adverse consequences or surgical delay were reported.

• 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: 8150151
• Report Number: 0009617544-2018-00296
• Device Sequence Number: 11205182
• 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): 02/25/2019

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: 10G517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1