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

Model Number 228143

Device Problems Loose or Intermittent Connection (1371); Device-Device Incompatibility (2919); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2020

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, after 1st firing, two plates were deployed at the same time.Changed another two to continue the surgery, the same problem happened again.Changed another one to continue the surgery, it was reported that the firing trigger was loosed.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

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.Investigation summary: according to the information provided, it was reported that during the surgery of meniscus repair, after the first firing, two plates were deployed at the same time in two devices.Additionally, it was reported that in two devices, the firing trigger was loose.The complaint devices are not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.Since the complaint devices were not returned, we cannot determine a root cause for the reported failure.If the devices are received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [4l95748] number, 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: 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: 10774565
• MDR Text Key: 214392783
• Report Number: 1221934-2020-03283
• 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
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Device Lot Number: 4L95748
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2020
• Patient Sequence Number: 1