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

Model Number 228161

Device Problems Break (1069); Failure to Fire (2610); Physical Resistance/Sticking (4012)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the red trigger didn¿t respond.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received and the photo provided by the 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.Biological residues were found in the needle.The photo showed only the label of the device.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:5l95397, and no nonconformances were identified.Based on the condition of the device received, this complaint can be confirmed.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.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.

Event Description

It was reported by the sales rep in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the red trigger on the truespan 12 degree plga device did not respond.During in-house engineering evaluation, it was determined that the initial part of the trigger was broken and disconnected from the firing spring indicating that the internal mechanism of the handle was not working on the device.Another like device was used to complete the procedure with a delay of five minutes.There were no 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: 12737477
• MDR Text Key: 279593519
• Report Number: 1221934-2021-03222
• 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
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 228161
• Device Catalogue Number: 228161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1