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

Model Number 228151

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 02/26/2021

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).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 customer in (b)(6) that during a knee arthroscopy for a meniscal repair procedure on (b)(6) 2021, it was observed that an unusual sound was heard when the trigger on the truespan 12 degree peek device was pressed; and did not activate the suture as the tip was seen only halfway.According to the reporter, the trigger was loose that it did not activate the gun.Another like device was used to complete the procedure.There was no surgical delay nor 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 received, it was reported that during the surgery of knee arthroscopy, the injured meniscus requires meniscal suture.The first stitches are implanted with a 12-degree truespan peek: it is calibrated at 18, it is inserted into the knee with the help of the valve, and it is entered with the handle upwards to then give it its proper position and location, it works without problems.Given the injury, one more meniscal suture stitch is needed, so a 12-degree peek truespan was given.It was calibrated again at 18, introduced into the knee with the help of the valve and it was inserted with the handle upwards to then give it its proper position and location, it was positioned and penetrated the meniscus tissue according to the steps to follow, but in the moment the trigger was pressed, a sound was heard but the usual click was not heard.When the trigger of the meniscal suture was released, it was loose, it did not activate the gun and it was evident at the tip of the same that the peek has been halfway.Since the trigger did not activate the suture, this prevented the passage of the stitches with this implant, for this reason a new suture was given, this time of 0 degrees since there were no more units of 12 degrees.Its passage through the tissue was difficult since it is not the appropriate inclination for the location, but it managed to pass and implant the stitches.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos and video were provided.Upon visual inspection of the photos, it appeared that the implants and suture were not deployed.Also, the video showed that the trigger was loose, in that there was no tension on the handle.A manufacturing record evaluation was performed for the finished device lot number: 6l68692, and no nonconformances were identified.Hands on analysis should observe the condition of the internal mechanism of the gun and provide the evidence necessary to determine a specific root cause.Based on the condition of trigger, this complaint can be confirmed.This type of issue was reviewed before with the manufacturer, based on the information, 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.The possible root cause for the reported failure could be related when feel a resistance and excessive force could have caused stress on the handle thus causing the handle mechanism to break.However, given the evidence we cannot discern a definitive root cause for the reported failure.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, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• 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: 11486170
• MDR Text Key: 240578884
• Report Number: 1221934-2021-00847
• 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
• Report Date: 03/01/2021

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: 6L68692
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 19 YR