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

Model Number 279702030

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The expedium straight thoracic pedicle probe was returned to the complaint handling unit (chu).The probe is broken at the 40mm graduation mark.The distal end of the tip that broke off was not returned.Fracture analysis was subsequently performed on the broken device.Optical imaging of the fractured surface of the device reveals a rough surface.This indicates a single, sharp, heavy load being placed on the tip.The probe may have been torqued sharply during use.No material defects of other abnormalities were observed in this analysis.Hardness testing showed the device to be within specifications.A device history record review did not find any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the tip of the device breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is static overload failure due to a single, sudden, unexpectedly high force placed on the tip.As no issues could be identified in the manufacturing or release of this product.Therefore, this complaint 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.

Event Description

It was reported that the pedicle finder snapped off during an unknown procedure on an unknown date.This was possibly due to wear and tear from continual use.There was no surgical delay reported, since there was a spare pedicle finder that was used to continue the procedure.There was no impact to the patient.Procedure outcome was unknown.

• Brand Name: XPDM THORACIC PEDICLE PRB, ST
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8533800
• MDR Text Key: 144154294
• Report Number: 1526439-2019-51545
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198439
• UDI-Public: (01)10705034198439
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2018

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
• Device Operator: Health Professional
• Device Model Number: 279702030
• Device Catalogue Number: 279702030
• Device Lot Number: 1010NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2010
• 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