MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Model Number 228143

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/15/2022

Event Type  malfunction  

Event Description

It was reported by the customer in (b)(6) that preoperatively to a meniscal repair procedure on (b)(6) 2022, it was observed that there was a foreign material inside the packaging of meniscal deployment gun device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

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., the complaint device was returned and evaluated.Upon visual inspection, the device is inside in a completely sealed blister.The foreign matter is not visible trough the transparent blister.The seal was removed to verify the inside.A hair of 5cm was found inside.A manufacturing record evaluation was performed, for the finished device 8l36778 number.And no non-conformances were identified.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection and the functional test result, this complaint can be confirmed.The device was evaluated by the manufacturer with the following results: the parameters for the clean room were reviewed and found to be in conformance.Also, there is a certification/training for all the people that manufactures the product.According with the findings previously mentioned, we can conclude, that this is an isolated occurrence.An nc was opened to track this failure with the supplier a deeper investigation will be performed under this action.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information, for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13662234
• MDR Text Key: 290650434
• Report Number: 1221934-2022-00713
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Device Lot Number: 8L36778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1