MAUDE Adverse Event Report: DEPUY SPINE INC BALL POINT PEDICLE FEELER; PROBE

Catalog Number 274430000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

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

On (b)(6) 2018, the surgery for degenerative disease was performed by using the mountaineer system.The fixed area was c4 ¿ c6.When the device in question was used, it had been bent.So, the bending part was fixed.When the same device was used again, the tip of the device in question was broken.The broken part was about 2 cm from the tip.The surgery was completed with no delay, and there was no adverse consequence to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fracture was located toward the probe¿s distal tip.The second part of the tip was not provided for evaluation.Device was then sent for fracture analysis.The fracture analysis report shows evidence of plastic deformation and a rough appearance across the entire surface, indicating that the probe underwent a static overload failure.No material defects or other abnormalities were observed in this analysis.A review of the device history record (dhr) for the ball point pedicle feeler could not be performed.Multiple attempts to attain dhr review was conducted.However, lot number could not be found.Therefore, without the lot number, no review of the manufacturing records could be completed.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the pedicle feeler¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report shows evidence of plastic deformation and a rough appearance across the entire surface, indicating that the probe underwent a static overload 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: BALL POINT PEDICLE FEELER
• 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: 7291230
• MDR Text Key: 100935535
• Report Number: 1526439-2018-50160
• Device Sequence Number: 1
• Product Code: HXB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 274430000
• Device Lot Number: P983533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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