MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Model Number 228143

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.Initial reporter phone number: (b)(6).Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported that during the surgery of meniscus repair, 228143's firing trigger was loose, the surgeon suspect the spring was stuck.Changed new 228143 with 228141, after 1st firing, two plates were deployed.All 228141s were with same issue.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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.D4, h4: the expiration date and device manufacture date were reported as unknown on the initial report.Both fields have been updated accordingly.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.D3, d4: the manufacturer name and lot number have been updated to reflect the correct information.Udi: (b)(4).

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
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> according to the information provided, it was reported that during the surgery of meniscus repair, 228143's firing trigger was loose, the surgeon suspect the spring was stuck.Changed new 228143 with 228141, after 1st firing, two plates were deployed.All 228141s were with same issue.The complaint device was received and evaluated.Visual observations reveal that the meniscal deployment gun was intact, it did not present any physical damage.When the functionality was tested any defect was observed, both triggers were works as intended.Based on the received condition of the gun and there no more information about this failure, this complaint cannot be confirmed, and we cannot discern a specific root cause for this issue reported.  a manufacturing record evaluation was performed for the finished device lot number:5l95466, 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.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.

• Brand Name: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle MA CH-24 00; SZ CH-2400
• MDR Report Key: 10782339
• MDR Text Key: 214573712
• Report Number: 1221934-2020-03305
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Device Lot Number: 5L95466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 01/10/2021
• Patient Sequence Number: 1