MAUDE Adverse Event Report: DePuy Mitek LLC US MENISCAL DEPLOYMENT GUN; Applier, Staple, Surgical,

Catalog Number	228143
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the meniscal deployment gun device was deformed/bent.It was noted in the service order that the device had an unspecified malfunction.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that it was returned in used condition.The spring pusher was found bent.The overall complaint was confirmed as the observed condition of the meniscal deployment gun would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the bending of the spring pusher during loading the needle into the gun.As per the instructions for use; provides the steps for a proper needle assembly.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: there was no non conformance regarding this lot.

• Brand Name: MENISCAL DEPLOYMENT GUN
• Common Device Name: Applier, Staple, Surgical,
• Manufacturer (Section D): DePuy Mitek LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50483370
• Report Number: 1221934-2026-03850
• Device Sequence Number: 13346906
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: (01)10886705010059(10)10AHCA(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 228143
• Device Lot Number: 10AHCA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown