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

Model Number 228151

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) incomplete 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 surgery on 1/12/2021, it was observed that the handle on the truespan 12 degree peek device was broken that the device jammed and did not fire.Another like device was used to complete the procedure.There were no 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.H11 additional narrative: investigation summary : according to the information provided, it was reported that during the surgery of meniscus repair, could not fire again after 1st firing, and the firing trigger was loose.No additional information could be provided.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received provided by customer.The complaint device was received and inspected.The sleeve was cut to see the internal condition; as a result, the implants and suture were received along with the needle, they were not deployed.Also, it was observed that the pusher rod was bent and protruded of the sleeve.When test its functionality, it was also observed that the trigger was loose, in that there was no tension on the handle from the spring.Therefore, the gun was opened, and it was found that the initial part of the trigger was broken and disconnected from the firing spring, it indicates that the internal mechanism of the handle was not working.A manufacturing record evaluation was performed for the finished device lot number: 6l68363, and no nonconformances were identified.This type of issue was reviewed with the manufacturer, based on the information received, the process of the truespan have two phases where the deployment gun is checked (the step of applier functional testing and the implant system routing check), this test guaranties the applier has been properly assembled and is functional.This information correspond to a process control and it is the appropriate document to use to guarantee that this issue can¿t have happened during manufacturing process.No information was provided on how this failure has occurred or specifications of the procedure, therefore a definitive root cause could not be determined.The possible root cause for the reported failure could be related when not inserting the needle to the proper depth for deployment which have caused that the implant not be deployed as intended which could cause stuck.When attempted to fire the implant against the tissue, it can feel a resistance and excessive force could have caused stress on the handle thus causing the handle mechanism to break.However it cannot be conclusively affirmed.As per ifu, for the needle insertion, it is necessary use a calibrated probe, measure the width of the meniscal tissue to help insert into the joint.Set the adjustable depth stop to minimize tissue penetration depth.Also, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging tissue.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of 100 devices that were released to distribution.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that another like device was used to complete the procedure with a delay of ten minutes to get the new device from the storage.The time of anesthetic was slightly prolonged due to the event.There was no surgical intervention planned.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• 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: 11307760
• MDR Text Key: 232524592
• Report Number: 1221934-2021-00475
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• 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: 01/26/2021

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: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 6L68363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/16/2021; 03/16/2021
• Supplement Dates FDA Received: 02/17/2021; 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1