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

Model Number 275010140

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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 feeler probe broke as the surgeon was trying to adjust it to straighten it out.

Manufacturer Narrative

Product complaint # (b)(4).

• Brand Name: BALL TIP FEELER STRAIGHT
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8537401
• MDR Text Key: 142678306
• Report Number: 1526439-2019-51554
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034194066
• UDI-Public: (01)10705034194066
• 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
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

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: 275010140
• Device Catalogue Number: 275010140
• Device Lot Number: 1110V
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1