MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - GRASPING/HOLDING INSTRUMENTS; SUTURE/NEEDLE PASSER

Catalog Number UNK - GRASPING/HOLDING INSTRU

Device Problem Break (1069)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported by an affiliate that during an unspecified surgical procedure on (b)(6) 2024 the grasping holding tool device graspers were broken.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the device manufacture date was unknown.D4: the device lot number was unknown.D4: udi: (b)(4).

• Brand Name: UNK - GRASPING/HOLDING INSTRUMENTS
• Type of Device: SUTURE/NEEDLE PASSER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19164495
• MDR Text Key: 341182830
• Report Number: 1221934-2024-01246
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - GRASPING/HOLDING INSTRU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2024
• 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