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 Date 11/10/2020

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 sales rep that during an anterior cruciate ligament reconstruction, it was observed that the truespan meniscal repair system peek 12 degree device got stuck in the inserter and would not deploy.Another device was used to complete the procedure.No patient consequences, or 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.Investigation summary: according to the information provided, it was reported that during an anterior cruciate ligament reconstruction two of the truespan meniscal repair system peek 12 degree got stuck in the inserter and would not deploy.The two devices were received without lot number.Visual inspection of the first device revealed that both implants were received with the gun.One implant appeared to be partially deployed due to it was found still in the needle and the other implant was in place.There were not anomalies identified in the silicone sleeve.Via functionality test, the trigger functioned as expected, and when the trigger was pressed fully a click sound was heard the first implant deployed as expected, and when the trigger was re-pressed for the second time, the main pusher rod was deployed again and deployed the last implant.Also, the red trigger was tested several times and it works as intended.Based on the result of the functional test, the complaint reported cannot be confirmed.We cannot determine a specific root cause.The possible root cause for the deployment failure reported could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion of the first implant, and when this occurred may have felt resistance and did not pull the trigger all the way.This would result in the first implant being only partially deployed.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number: 6l65927, 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.

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.D9, 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.

• 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: 10927733
• MDR Text Key: 218952425
• Report Number: 1221934-2020-03633
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

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 Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 6L65927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 12/20/2020
• Supplement Dates FDA Received: 12/16/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1