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	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic meniscal repair procedure the omnispan meniscal repair 12deg device had both plates deployed at the same time.Another device was used to complete the procedure.There was a 5 minute delay in the procedure reported.There were no adverse patient consequences reported.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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.The product was not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo found that the needle was deformed and the sleeve was broken, however the plates and the suture cannot be observed.Without these components, it is not possible to confirm the reported condition.No other anomalies could be observed on the device.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 investigation findings, it is possible that there was a failure to use a malleable graft retractor to guide the needle during the insertion.As per ifu 109282, 1) use a malleable graft retractor to protect the implants and suture from getting caught on soft tissue, including the fat pad, during insertion into the knee.Once inside the joint space, remove the malleable graft retractor.Alternatively, an arthroscopic cannula may be utilized.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.Document specification review: ifu-109282.Device history lot: pn: 228141.Lot number: 1082tb.There was no non-conformance regarding this lot.Manufacturing date: 29 apr 2025.Expiration date: 31 mar 2028.Device history batch: null.Device history review: pn: 228141.Lot number: 1082tb.There was no non-conformance regarding this lot.Manufacturing date: 29 apr 2025.Expiration date: 31 mar 2028.E1: the reporter¿s complete facility address was not 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: 25084887
• Report Number: 1221934-2026-01909
• Device Sequence Number: 10532507
• Product Code: MBI
• UDI-Device Identifier: 10886705010035
• UDI-Public: (01)10886705010035(10)1082TB(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

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: 1082TB
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/03/2026; 06/08/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/04/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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
• 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