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

Catalog Number	228141
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
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 was returned to depuy synthes for evaluation.Visual inspection of the returned device found only the suture with one plate attached to it.The suture was tangled, broken and frayed.No other anomalies were found.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, it is possible that an excessive force was applied to the suture while tightening.As per instruction for use 1) use caution when tensioning the suture.Over-tensioning may cause suture or implant breakage.Properly handling and attention to the approved use of the device diminishes the risk of failure.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.
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: e1: the reporter¿s complete facility address was not provided.Investigation summary.The product was not returned to depuy synthes, however photos were provided for evaluation.Visual inspection of the returned photo found that the suture was detached from the needle, tangled and frayed.Only one of the two plates was visible.No other anomalies were found.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, it is possible that an excessive force was applied to the suture while tightening.As per the instructions for use (ifu): 1) use caution when tensioning the suture.Over-tensioning may cause suture or implant breakage.Properly handling and attention to the approved use of the device diminishes the risk of failure.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 during a meniscal repair surgical procedure it was observed that the suture of the omnispan meniscal repair 12deg device was winding.It was reported that another device was used to complete the procedure.During in-house engineering evaluation it was determined that the suture was detached from the needle, tangled and frayed.There were no reported adverse consequences to the patient.No additional information could be 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: 25195130
• Report Number: 1221934-2026-02057
• Device Sequence Number: 10565666
• Product Code: MBI
• UDI-Device Identifier: 10886705010035
• UDI-Public: (01)10886705010035(10)1085SQ(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092836
• 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

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: 1085SQ
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 05/16/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2025
• 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