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

Catalog Number	228141
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
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 not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo found that the device is shown in used condition, both plates are shown deployed.The needle is in good condition.No other issues 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.Device history review: there was no non conformance regarding this lot.Based on the investigation findings, the potential cause is traced to when the loading rod (red trigger) is being pressed accidentally before pressing the deployment rod (grey trigger), pulling the red trigger before the first shot will place the second plate to the deploying position and when the gray trigger is pressed, both implants will be deployed at the same time; as per the instructions for use; the proper deploying sequence is 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.
Event or Problem Description
It was reported that during meniscal repair surgery, after 1st firing of the omnispan orthocord device, two plates were deployed at the same time.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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: corrected: h3.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that it was returned in used condition, both plates are deployed.The needle is in good condition.No other issues 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, the potential cause is traced to when the loading rod (red trigger) is being pressed accidentally before pressing the deployment rod (grey trigger), pulling the red trigger before the first shot will place the second plate to the deploying position and when the gray trigger is pressed, both implants will be deployed at the same time; as per instruction for use.The proper deploying sequence is 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.Device history review- 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: the product was not returned to depuy synthes; however a photo was provided for evaluation.Visual inspection of the returned photo found that the device is shown in used condition, both plates are shown deployed.The needle is in good condition.No other issues 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, the potential cause is traced to when the loading rod (red trigger) is being pressed accidentally before pressing the deployment rod (grey trigger), pulling the red trigger before the first shot will place the second plate to the deploying position and when the gray trigger is pressed, both implants will be deployed at the same time; as per instruction for use.The proper deploying sequence is 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.Device history lot: 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: the actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once the investigation has been completed, a follow-up report will be submitted accordingly.

• 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: 24766096
• Report Number: 1221934-2026-01352
• Device Sequence Number: 21399636
• Product Code: MBI
• UDI-Device Identifier: 10886705010035
• UDI-Public: (01)10886705010035(10)10812D(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 10812D
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/22/2026; 04/22/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/22/2026; 04/23/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown