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

Model Number 228151

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

(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 affiliate in colombia that during a meniscal suture procedure on (b)(6) 2020, it was observed that the anchor device did not stay on the meniscus when fired but stayed at the tip of the gun.According to the report, the event occurred when the device was being positioned to accommodate the meniscus.There were no 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 wrrative: b5: subsequent follow-up with the customer, additional information was received.It was reported that the patient had no complications.It was further reported that the procedure did not have any delay as another device was available for use to supply the surgery.

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 received, it was reported that in the patient scheduled for meniscal suture surgery on (b)(6) 2020 by the doctor.The 24-degree truespan and the cutter are circulated and the guide is positioned, the guide is introduced, the meniscal suture is accommodated and the first shot is given at the bottom, the respective click is heard, when it is going to position again we notice that the peek it does not stay on the meniscus, it stays at the tip of the gun.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the first implant didn't deployed satisfactorily.A manufacturing record evaluation was performed for the finished device lot number: [6l68116], and no non-conformances were identified.The complaint reported was confirmed.The photo does not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause for the reported failure can be attributed to the tissue was penetrated at undesired depth.This cannot be conclusive determined.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: 11097475
• MDR Text Key: 224887504
• Report Number: 1221934-2020-04156
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 45 YR