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

Model Number 228161

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

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).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, it was observed that the truespan 12 degree plga device was blocked.It was reported that the handle remained stuck and the implants were not disposed.A new device was used to complete the procedure.There were no patient consequences.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: d10, 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.

Manufacturer Narrative

Product complaint (b)(4).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 truespan blocked during the procedure.The handle remained stuck (see enclosed picture) and the implants weren't disposed.The complaint device was received and inspected.The implants and suture were received along with the needle.It was observed that the gun was jammed.Also, it was identified that the shaft of the gun was bent.To test its functionality, the trigger could not pull due to it was loose; there was no tension on the handle.The main pusher rod was not actioned; thus, the implants did not deploy.Therefore, the internal mechanism of the handle was not working as intended.The photo provided by the customer showed the same analysis findings.The possible root cause for the bent issue could be attribute when not inserting the needle to the proper depth for deployment, can causing damage in the gun and could have a failure being fired.Also, for the deployed failure reported could be related to a damage on internal component of the deploy mechanism.Finally, for the trigger loose can be related when applies to much force during deployment of the implants.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number: 5l82005, and no non-conformances were identified. 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.Udi: (b)(4).

• 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: 10246676
• MDR Text Key: 198864714
• Report Number: 1221934-2020-01777
• Device Sequence Number: 1
• Product Code: NBH
• 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: 06/24/2020

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: 08/31/2022
• Device Model Number: 228161
• Device Catalogue Number: 228161
• Device Lot Number: 5L82005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 08/16/2020
• Supplement Dates FDA Received: 07/23/2020; 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1