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

Catalog Number 228143

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A review into the depuy synthes mitek complaints system revealed no similar complaint of any kind for this lot of devices that were released to distribution.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.(b)(4).Associated medwatches: 1221934-2018-50438 and 1221934-2017-10681.

Event Description

The affiliate reported via email the first needle could be placed without problems with both applicators.After loading the second peek patch, the mechanics of the applicator jammed so that placement of the second patch was not possible.After placement of the first meniscus seam, the silicone sleeve of the needle body was released when the needle was removed from the joint gap.The silicone sleeve could be removed from the joint gap under sight.There was a delay of 5 minutes.Reply from affiliate (b)(6) 2017: four needles and two deployment guns were reported for this complaint.Did all four needles failed to deploy their second implant? no.Can you explain what happened after the first implant deployed successfully with the first gun? silicone sleeve came off the needle afterwards.Which size needle was used? 12°.Once the gun jammed, is that when the silicon sleeve fell into the patient¿s joint space? no.Was the silicon sleeve removed from the patient at this time? yes.Did the surgeon remove the first implant? yes.Were the first implants left in the patient? no.If so, how were they secured? if the implant was removed, did the surgeon cut the suture, or cut the meniscus to remove the first implant? cutting the suture.Did this damage the meniscus tissue? no.What happened after the first implant deployed successfully with the second gun.Which size needle was used here? 27°.How was the procedure completed? with competitive product was the procedure completed with same like product? no.Was there a resulting surgical delay - how long? yes.5 minutes.Was the procedure able to be completed? yes.Were alternatives readily available? yes.Any patient impact? no.Can you please explain in detail exactly what issue occurred with the 2 guns and 4 needles? did all 6 devices fail? unk.Can you please provide me the part number/lot numbers for the needles that failed? please see lot numbers in attached complaint form.Which one of the 2 deployment guns had the detached silicone sleeve? did this occur to both guns? deployment gun with detached sleeve has been returned.Customer did not comment on second gun.

• Brand Name: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7468340
• MDR Text Key: 107209492
• Report Number: 1221934-2018-50439
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 228143
• Device Lot Number: L436641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1