MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Model Number 228143

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2020

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).

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.Investigation summary: 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.Another device was used to complete the surgery.The meniscal deployment gun (228143) was received and evaluated.On visual inspection it could be observed that the device is in normal use conditions, no structural damages were found.The firing trigger (dark gray) was tested for its functionality several times, it performed as intended, also the loading trigger (red) was tested and worked as usually.The slider deployment and the rod loader were inspected for damages or bending, no anomalies were found.A new needle was used for performing the functional test.The needle was positioned into the deployment gun shaft.The needle was introduced into the rubber meniscal sample.The first implant was triggered with no problem.The loading trigger (red) was activated, the second implant was positioned for the second shot with no anomalies.The second implant was triggered with no problem, the sutures and plates showed a good behavior while triggering.According with the visual inspection result and the functional test performed, this complaint cannot be confirmed.Considering that both trigger and functional tests were passed, we cannot determine a root cause why the customer experienced the reported failure.A manufacturing record evaluation was performed for the finished device [6l38031] number, and no non-conformances were identified.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to 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.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): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10780739
• MDR Text Key: 214568919
• Report Number: 1221934-2020-03299
• 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
• 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: 07/31/2022
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Device Lot Number: 6L38031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 12/20/2020
• Patient Sequence Number: 1