MAUDE Adverse Event Report: DEPUY SPINE INC UNAV CLAMP ATTACHMENT, SM ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 286755010N

Device Problem Break (1069)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Only event year is known. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a j&j employee. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date, that during an unknown procedure, it was observed that the universal navigation clamp attachment device broke. There were no surgical delays reported. No fragments remained in the patient. The patient¿s outcome was stable. No further information is available. This report involves one (1) unav clamp attachment, sm. This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNAV CLAMP ATTACHMENT, SM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 14119521
• MDR Text Key: 289359180
• Report Number: 1526439-2022-00573
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 286755010N
• Device Catalogue Number: 286755010N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2022
• 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: Unkown