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

Catalog Number	228141
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a meniscal repair surgical procedure, it was observed that the suture of the omnispan meniscal repair 12deg device was winding, which lead to the device not firing.It was reported that the surgeon changed to another omnispan meniscal repair 12deg device to continue the surgery, and the same problem happened again.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This is report 2 of 2 for (b)(4).
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: investigation summary: the product was not returned to depuy synthes for evaluation; however a photo was provided for evaluation.Visual inspection of the returned photo revealed that the device is shown in used condition.Both plates are already deployed.The needle is in good condition.Both plates are in good condition as well as the suture.The suture shows no winding.The overall complaint was not confirmed as the observed condition of the omnispan meniscal repair 12deg would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established due to the insufficient evidence 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.

• 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 ; +1(908)386-3534
• MDR Report Key: 50034407
• Report Number: 1221934-2026-03288
• Device Sequence Number: 13217835
• Product Code: MBI
• UDI-Device Identifier: 10886705010035
• UDI-Public: (01)10886705010035(10)107X0L(17)280331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup,Followup,Followup,Followup

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: 107X0L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2026
• Supplement Date Received by Manufacturer: 08/24/2026; 08/27/2026; 08/28/2026; Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/25/2026; 08/28/2026; 08/31/2026; 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown