MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO GRASPER PEN 35 UP *EA; ACCESSORIES, ARTHROSCOPIC

Catalog Number 214601

Device Problem Difficult to Open or Close (2921)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported by the sales rep that during an unspecified surgical procedure on (b)(6) 2023 the arthro grasper pen 35 up device up jaw was not closing properly.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.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 mitek or its employees that the report constitutes an admission that the device, 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.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.H10 additional narrative: e3: reporter is a j&j sales representative.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

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.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.

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.The device was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection, the device was found to be worn.When the trigger was actuated to test for its functionality, the upper jaw doesn¿t open completely contributing to the holding issue; therefore, this complaint can be confirmed.The tip appeared to be slightly deformed causing that the jaw and teeth did not align properly.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.The lot number provided indicates this device is two years old and has seen considerable use in the field which is consistent with its appearance.This failure can be attributed to the wear or damaged from heavily handling.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raymham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17977212
• MDR Text Key: 326173874
• Report Number: 1221934-2023-03819
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

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 Catalogue Number: 214601
• Device Lot Number: 21E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/09/2023; 12/05/2023
• Supplement Dates FDA Received: 11/15/2023; 12/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1