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 Foreign Body In Patient (2687)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.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 (b)(6) that during a knee arthroscopy procedure on (b)(6) 2020, it was observed that the meniscal deployment gun device was showing resistance on its trigger when the first implant was fired even though the needle was properly inserted.The first implant was placed in the meniscus without a hitch despite the resistance of the gun.When the red trigger was pressed to slide the second implant towards the tip of the needle the gun resisted, fired the second implant with the gray trigger, and the second implant jammed along with the trigger.This did not allow the second implant to enter the meniscus and remain floating in the intra-articular space.The surgeon cut the remaining suture and removed it from the joint, cut the suture from the second implant and reached for it to remove it.However, he was unable to retrieve the fired implant.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 will be filed as appropriate.Investigation summary =according to the information provided, it was reported that on (b)(6) 2020 during knee arthroscopy surgery with meniscal repair; omnispan' s pistol failed.The needle was properly inserted by our technician.At the time the dr.Fired the first implant he reported to us that the gun was showing resistance on the trigger.He proceeded to place the first omnispan implant in the meniscus without a hitch despite the resistance of the gun.When the red trigger was pressed to slide the second implant towards the tip of the needle the gun resisted, fired the second implant with the gray trigger, and the second implant jammed along with the trigger.This did not allow the second implant to enter the meniscus and remain floating in the intra-articular space.The dr.Cut the remaining suture and removed it from the joint, cut the suture from the second implant and reached for it to remove it; however, he was unable to retrieve the fired implant.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, 4 photos were provided.Upon visual inspection of the photos, the exterior of both sides of the device are visible, no structural anomalies could be observed, the distal tip of the shaft is visible, the slider and the lever deployment rods could be observed, no structural damages are visible.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the photos provided can only provide the exterior appearance of the device.Hands on the device would provide an accurate analysis outcome.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• 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: 11013244
• MDR Text Key: 225336021
• Report Number: 1221934-2020-03876
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention