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

Model Number 279702040

Device Problem Break (1069)

Patient Problems Injury (2348); Not Applicable (3189)

Event Date 02/21/2018

Event Type  Injury  

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 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.

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
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7357090
• MDR Text Key: 103023473
• Report Number: 1526439-2018-50262
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198446
• UDI-Public: (01)10705034198446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 152