MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 27DEG; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 228142

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: (b)(4) to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent accordingly.

Event Description

It was reported from china that during a meniscal repair procedure, it was observed that the needle on the omnispan meniscal repair 27deg device broke off.Another like device was used to complete the procedure.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary: the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted visual inspection of the returned device.Visual inspection found that omnispan meniscal repair 27deg had the needle broke still inside the sleeve.Implants were not deployed.No additional damage was observed on device surface.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the omnispan meniscal repair 27deg would contribute to the complained device issue.Based on the investigation findings, the potential cause could be traced to the procedural variables, such handling of the device or product interaction during procedure.As per ifu, it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.Also, it is important to fully squeeze the deployment lever (dark grey) while maintaining depth positioning to deliver the first implant.There may be a slight pushback on the deployment gun while the implant goes through the tissue, and 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 mitek 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: a review of the batch manufacturing records was conducted on finished lot number 9l31960; and no related non-conformances were identified.

• Brand Name: OMNISPAN MENISCAL REPAIR 27DEG
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19184660
• MDR Text Key: 341379700
• Report Number: 1221934-2024-01367
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010042
• UDI-Public: 10886705010042
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 228142
• Device Lot Number: 9L31960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/07/2024; 05/13/2024
• Supplement Dates FDA Received: 05/09/2024; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1