MAUDE Adverse Event Report: DEPUY SPINE INC XPDM THORACIC PEDICLE PRB, CRV; PROBE

Model Number	279702040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
While inserting the expedium thoracic probe into the l5 pedicle the tip of the probe broke off into the pedicle.About 20 mm.The surgeon had to drill out the pedicle in order to retrieve the tip.Also while inserting a pedicle screw the tip of the expedium poly driver broke off into the tulip,of the screw.The tip was not able to be retrieved.It remains in the screw.Patient consequence?: yes.Patient consequence description:additional exposure to anesthesia plus the l5 pedicle was almost not a viable fixation point.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed a fracture of the probe¿s distal tip, approximately 40mm from the distal end.Device was then sent for fracture analysis.The fracture analysis report reveals plastic deformation at the corners and torsional shear markings following a circular pattern.This suggests that the fractured tip underwent a quasi-static overload torsional shear failure.No material defects or other abnormalities were observed in this analysis.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the pedicle probe¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report suggests that the fractured tip underwent a quasi-static overload torsional shear failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: XPDM THORACIC PEDICLE PRB, CRV
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7357090
• Report Number: 1526439-2018-50262
• Device Sequence Number: 2312319
• Product Code: HXB
• UDI-Device Identifier: 10705034198446
• UDI-Public: (01)10705034198446
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279702040
• Device Catalogue Number: 279702040
• Device Lot Number: 0610NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 152