MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OMNISPAN MENISCAL REPAIR 27DEG; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	228142
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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: investigation summary: the product was not returned to depuy synthes; however, a photo was provided for evaluation.Visual inspection found that the suture with one plate was detached from the needle.The plate had no anomaly; however, the suture was broken and frayed.No other anomaly could be observed.The overall complaint was not confirmed as the observed condition of omnispan meniscal repair 27deg would have not contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure.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, when using the omnispan meniscal repair 27deg anchor device, it was observed that after the 1st firing, two plates were deployed at the same time.It was reported that another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Brand Name: OMNISPAN MENISCAL REPAIR 27DEG
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24288242
• Report Number: 1221934-2026-00628
• Device Sequence Number: 21188781
• Product Code: MBI
• UDI-Device Identifier: 10886705025923
• UDI-Public: (01)10886705025923(10)105JL7(17)271231
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 228142
• Device Lot Number: 105JL7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• 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