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

Model Number 279702040

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

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

It was reported that the tip of the pedicle probe broke.It is a old instrument.It happened during surgery, no harm to patient.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fracture was located at 40mm from the probe¿s tip.The second half of the probe¿s tip was also returned.The fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure.The absence of rotational deformation and a termination site implies that the probe was broken under a cantilever force.The static overloading led to a fracture of the tip.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 probe¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report reveals uniform rough morphology of the fractured surface indicating that the instrument underwent a static failure due to a single, sudden, unexpectedly high force placed on the tip of the device.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
• MDR Report Key: 8422211
• MDR Text Key: 140318161
• Report Number: 1526439-2019-51466
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198446
• UDI-Public: (01)10705034198446
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279702040
• Device Catalogue Number: 279702040
• Device Lot Number: NW106670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1