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	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an l5/s1 plif procedure was performed for l5 spondylolytic spondylolisthes.The pedicle marker was inserted to insert a pedicle screw.In the last image taken after suturing, the surgeon confirmed that the tip of the marker was left on the left of s1.Therefore, the wound was re-opened to retrieve and remove the fragment.There was a reported 30 minute delay.
Event or Problem Description
It was reported that an l5/s1 plif procedure was performed for l5 spondylolytic spondylolisthes.The pedicle marker was inserted to insert a pedicle screw.In the last image taken after suturing, the surgeon confirmed that the tip of the marker was left on the left of s1.Therefore, the wound was re-opened to retrieve and remove the fragment.There was a reported 30 minute delay.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the customer reported event was confirmed via visual inspection.The device was returned in 2 pieces with 10mm of the tip fractured away from the rest of the device.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device was manufactured in 2010.The device was found to be over 8 years old at the time of the event.The instruments ifu states that "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." additionally, applying cantilever or off axis force onto the marker could cause the tip to fracture.Conclusion: the most likely root cause is cantilever or off axis force was applied to the marker to cause the tip to fracture.Additionally, the age and wear due to the device's extended use can contribute to the tip fracturing.

• 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: 7975708
• Report Number: 0009617544-2018-00242
• Device Sequence Number: 182937
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 10G519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR