MAUDE Adverse Event Report: DEPUY SPINE INC. SOUNDING PROBE - STRAIGHT; ORTHOPAEDIC FEELER

Model Number 277010140

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported by the sales rep customer in united kingdom that the ball tip feeler device was broken.There was no procedure nor patient involvement reported.No additional information was provided.This report is for one (1) sounding probe - straight device.This complaint involves one (1) device.

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Without a lot number the device history records review could not be completed.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: SOUNDING PROBE - STRAIGHT
• Type of Device: ORTHOPAEDIC FEELER
• Manufacturer (Section D): DEPUY SPINE INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14221256
• MDR Text Key: 292510764
• Report Number: 1526439-2022-00620
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034196251
• UDI-Public: 10705034196251
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 277010140
• Device Catalogue Number: 277010140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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