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

Model Number 228151

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: (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.

Event Description

It was reported by the affiliate in (b)(6) that during an unknown surgery on an unknown date, it was observed that the truespan 12 degree peek device could not be fired as the lever was jammed and could not be pressed completely down.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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.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.

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 narratie: investigation summary : according to the information provided, it was reported that the device could not be fired, jammed, lever could not completely press down.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection, it was identified that the sleeve was damage.Biological residues were identified near the first implant.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.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; therefore, is not possible to confirm the stuck condition.A manufacturing record evaluation was performed for the finished device lot number: 7l43568, and no nonconformances were identified.Based on the condition of the device received, this complaint can be confirmed.This type of issue was reviewed before 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.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.

• 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: 12350343
• MDR Text Key: 267668583
• Report Number: 1221934-2021-02549
• 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: 08/11/2021

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 Expiration Date: 09/30/2023
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 7L43568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 09/17/2021; 09/28/2021
• Supplement Dates FDA Received: 09/20/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1