MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN ORTHOCORD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	228141
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
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 first plate partially deployed.The needle and the suture were not placed in their original white paperboard packing.The deployed plate had foreign matter, presumably biological residue.No other anomalies could be observed.As the device show signs of use, the reported complaint of failure without use cannot be confirmed.The overall complaint was confirmed as the observed condition of the omnispan meniscal repair 12deg would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the handling of the needle during the procedure, it is possible that the plate was deployed while performing the assembly process into the meniscal gun.As per ifu, proper use instructions are provided.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.There was no non-conformance regarding this lot.
Event or Problem Description
It was reported that during a meniscal repair surgical procedure it was observed that the omnispan orthocord device plate detached in the packaging.Opened the packing (did not use), noted the plate was detached (as the attached.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.

• Brand Name: OMNISPAN ORTHOCORD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25113923
• Report Number: 1221934-2026-01958
• Device Sequence Number: 9326506
• Product Code: MBI
• UDI-Device Identifier: 10886705010035
• UDI-Public: (01)10886705010035(10)1084A5(17)280331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 228141
• Device Lot Number: 1084A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 06/03/2026; 06/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/04/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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