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

Model Number	48237081
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon marked his pedicles with pedicle markers.When they took a lateral x-ray to confirm the location we noticed the pedicle in l4 was broken off.He could not retrieve the broken tip from the pedicle and left it in the patient.
Additional Manufacturer Narrative
Method: visual analysis; device history review, complaint history review, risk assessment.Result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The visual inspection of the device showed that the pedicle was fractured at the tip.Conclusion: the plausible root cause of the event was determined to be -use error- excessive force applied to get through the resistance provided by an unsuitable angle resulting in the fracture of the device.
Event or Problem Description
It was reported that; surgeon marked his pedicles with pedicle markers.When they took a lateral x-ray to confirm the location we noticed the pedicle in l4 was broken off.He could not retrieve the broken tip from the pedicle and left it in the patient.

• 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: 6635403
• Report Number: 0009617544-2017-00237
• Device Sequence Number: 1082946
• Product Code: LXH
• UDI-Device Identifier: 07613327265590
• UDI-Public: (01)07613327265590
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/24/2017

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 Model Number: 48237081
• Device Catalogue Number: 48237081
• Device Lot Number: 104161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR