MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PLGA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228161

Device Problem Mechanical Jam (2983)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The expiration date is currently unavailable.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.

Event Description

It was reported by the affiliate in (b)(6) that during a knee arthroscopy procedure on an unknown date, it was observed that the implant on the truespan 12 degree plga device was blocked when it was fired.Another like device was used to complete the procedure.There was no delay or adverse patient consequences reported.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.H10 additional narrative: investigation summary: according to the information provided, it was reported that the device didn't function properly.When the surgeon tried to fire the first implant it was blocked.They had to take another like product and finish the refixation.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.Visual inspection reveals that there are no anomalies or structural damage on the outside of the device.It was identified that one implant was deployed and the other was still attached in the needle.To test its functionality, the red trigger was tested in the sample rubber strip and after actioned, the second implant was deployed without any difficult.A manufacturing record evaluation was performed for the finished device lot number: 6l75731, and no nonconformances were identified.Since the condition of the device received and the result of the functionality test, we cannot confirm this complaint.No additional information was provided on how the failure has occurred; therefore, a definitive root cause could not be determined.The possible root cause for the experience reported by the customer could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion of the first implant, and when this occurred may have felt resistance and did not pull the trigger all the way.Also, the trigger might have not fully been pressed until a click sound was heard which could cause the reported failure.However, it cannot be conclusively affirmed.As per ifu-113244, 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 red deployment trigger while maintaining depth positioning to deliver the first implant.The implant is fully deployed when you hear an audible ¿click¿.Fully release the trigger after deployment.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Further, a review into the mitek complaints system revealed one dissimilar complaint for this lot of (b)(4) devices that were released to distribution.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

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.H10 additional narrative: b3, b5: the date of event was reported as unknown on the initial report; and has been updated accordingly.The event description has been updated to reflect this information.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in switzerland that during a knee arthroscopy procedure on (b)(6) 2021, it was observed that the implant on the truespan 12 degree plga device was blocked when it was fired.Another like device was used to complete the procedure.There was no delay or adverse patient consequences reported.No additional information was provided.

• Brand Name: TRUESPAN 12 DEGREE PLGA
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11455690
• MDR Text Key: 263861263
• Report Number: 1221934-2021-00813
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026043
• UDI-Public: 10886705026043
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

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 Model Number: 228161
• Device Catalogue Number: 228161
• Device Lot Number: 6L75731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/17/2021; 03/29/2021
• Supplement Dates FDA Received: 03/18/2021; 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1