MAUDE Adverse Event Report: DEPUY SPINE INC BALL TIP FEELER STRAIGHT; PROBE

Catalog Number 275010140

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

Surgeon was using ball tip feeler and it broke while in use.The broken tip was removed from the surgical site and both pieces were removed from the table.Patient consequence? :no.Action taken for procedure: another like instrument was obtained and the surgery was completed.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination revealed that the fracture is located approximately 16mm from the feeler¿s distal tip.Device was then sent for fracture analysis.The fracture analysis report shows plastic deformation and a rough appearance across the entire surface indicating that the feeler tip underwent a static overload 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.The root cause for the feeler¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report shows plastic deformation and a rough appearance across the entire surface indicating that the feeler tip 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 TIP FEELER STRAIGHT
• 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: 7303442
• MDR Text Key: 101205755
• Report Number: 1526439-2018-50183
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034194066
• UDI-Public: 10705034194066
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/08/2018

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: No Information
• Device Catalogue Number: 275010140
• Device Lot Number: TY17984
• 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: 02/08/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2014
• 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