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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MENISCAL DEPLOYMENT GUN; MENISCAL REPAIR IMPLANT APPLIER
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DEPUY MITEK MENISCAL DEPLOYMENT GUN; MENISCAL REPAIR IMPLANT APPLIER Back to Search Results
Catalog Number 228143
Device Problems Activation, Positioning or Separation Problem (2906); Activation Problem (4042)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2017
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.(b)(4).- incomplete.Depuy synthes has been informed that the lot number is not available.See associated medwatch: 1221934-2017-50108, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50113, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50117, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124.
 
Event Description
It was reported that the surgeon opened 15 implants and 13 were defective.Indeed, every time surgeon wanted to deliver the device, both implant (2) instead of 1 were delivered.Surgeon did not try to change the gun before opening every device.This is report 2 of 14 for complaint (b)(4).
 
Manufacturer Narrative
Corrected associated medwatch number below: device was used for treatment, not diagnosis.Udi: (b)(4).Depuy synthes has been informed that the lot number is not available.See associated medwatch: 1221934-2017-50108, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50117, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124, 1221934-2017-50126.
 
Event Description
It was reported that the surgeon opened 15 implants and 13 were defective.Indeed, every time surgeon wanted to deliver the device, both implant (2) instead of 1 were delivered.Surgeon did not try to change the gun before opening every device.This is report 2 of 14 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate udi: (b)(4) ¿ incomplete.The expiration date is not currently available.Associated medwatch report number: 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50113, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50117, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124, 1221934-2017-50126, 1221934-2018-55025.
 
Event Description
Additional information received from affiliate on 13 february 2018: it was reported that there was a delay in the procedure, but it is unknown how long the delay was.The procedure was completed using other anchors that were readily available.It is unknown if there were any procedural or patient anatomy factors which may have contributed to the breakage.The issue occurred during an initial procedure.No portion of the implant remained in the patient; no patient impact was reported.Additional information received from affiliate on 19 october 2018: a seventh 12 degree needle was returned due to having an issue related to the reported complaint.
 
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint gun discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Furthermore, no lot number was supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.But 14 needles (7 are 27-degree and 7 are 12-degree ones) were received and evaluated visually.Visual observations revealed first 12-degree needle has punched up silicon sleeve, second 12 degree has implants which are in released position but attached to the suture at the distal end of the silicon sleeve.The remaining five 12- degree needles are missing both implants and suture.The six of seven 27-degree needles are missing both implants and sutures.The seventh 27-degree needle had both implants are on needle slot near the distal tip of the needle, hence the implants were never deployed.No structural anomalies were observed on the needles or the implants.This failure mode results when loading rod (red trigger) is being pressed accidentally before pressing the deployment rod (grey trigger).Another possible root cause could be the deployment rod (grey trigger) is bent upwards, it can deploy both implants at the same time.Since the gun is discarded, we cannot discern any definite root cause at this point of time.At this 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) ¿ incomplete.The expiration date is not currently available.Associated medwatch report number: 1221934-2017-50108, 1221934-2017-50110, 1221934-2017-50111, 1221934-2017-50112, 1221934-2017-50113, 1221934-2017-50114, 1221934-2017-50115, 1221934-2017-50117, 1221934-2017-50119, 1221934-2017-50120, 1221934-2017-50121, 1221934-2017-50122, 1221934-2017-50124, 1221934-2017-50126, 1221934-2018-55025.
 
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Brand Name
MENISCAL DEPLOYMENT GUN
Type of Device
MENISCAL REPAIR IMPLANT APPLIER
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS SARL
chemin-blanc 38
le locle 2400
CH   2400
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7149024
MDR Text Key96125347
Report Number1221934-2017-50109
Device Sequence Number1
Product Code GEF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number228143
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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