MAUDE Adverse Event Report: DEPUY MITEK LLC US NIT MENSCL SUT NDL W2-0 OC 5PK; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	228145
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
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 has not returned to depuy synthes, however a photo was provided for evaluation.¿ visual inspection of the returned photo found the device carton open without the sutures packing visible.No other anomalies could be observed.The manufacturer performed an investigation of the photo provided with the following results: as per the information and the image provided with the complaint, suture is missing in the folder without evidence of the suture folder¿s precedence before.No capas or nrs have been found related to the defect reported in this complaint.The investigation performed showed that the production controls implemented at the non-sterile level as well as the in-process controls guarantee detection of issues related to missing components.100% of the product undergoes manufacturing controls for this kind of defect, and additionally every batch passes through quality inspection.Missing component defect could be caused during manufacturing but without further evidence, or the device, this cannot be confirmed.The overall complaint was confirmed as the observed condition of the nit menscl sut ndl w2-0 oc 5pk would have contributed to the complained device issue.¿ based on the investigation findings, a potential cause could not be established.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.
Event or Problem Description
It was reported that prior to a meniscal repair surgical procedure it was observed that the nit menscl sut ndl w2-0 oc 5pk device suture was missing.Another like device was used to complete the procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.
Event or Problem Description
It was reported that during service and evaluation, it was determined that the nit menscl sut ndl w2-0 oc 5pk device was missing components.It was reported in the service order that prior to a meniscal repair surgery it was observed that the device was missing features.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:.

• Brand Name: NIT MENSCL SUT NDL W2-0 OC 5PK
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23795481
• Report Number: 1221934-2025-04737
• Device Sequence Number: 20220533
• Product Code: NEW
• UDI-Device Identifier: 10886705010073
• UDI-Public: (01)10886705010073(10)106R3D(17)280131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 228145
• Device Lot Number: 106R3D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown