MAUDE Adverse Event Report: DEPUY MITEK OMNISPAN MENISCAL REPAIR 12DEG; SOFT-TISSUE MENISCAL REPAIR ANCHOR, BIOABSORBABLE

Catalog Number 228141

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

(b)(4).Device was used for treatment, not diagnosis.(b)(4) - incomplete.The expiration date is currently unavailable.See associated medwatch: 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 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, 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 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 5 of 14 for complaint (b)(4).

Manufacturer Narrative

Udi: (b)(4).The expiration date is currently unavailable.See associated medwatch: 1221934-2017-50108, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 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.

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 devices were received and evaluated visually.The seven needles cannot be distinguished as the batch/ lot number is not printed on the device.Visual observations revealed first has punched up silicon sleeve, second has implants which are in released position but attached to the suture at the distal end of the silicon sleeve.The remaining 5 are missing both implants and suture.The complaint is confirmed.No structural anomalies were observed on the needle 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.For the needle which has silicon sleeve punched up, the possible root cause of the defect could be the over-penetration during insertion.Since the gun is discarded, we cannot discern any definite root cause at this point of time.Nonconformance review was performed, overall no nonconformances were identified for all reported devices part-lot number combinations.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, 1221934-2017-50109, 1221934-2017-50110, 1221934-2017-50111, 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.

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, 1221934-2017-50113, 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.

• Brand Name: OMNISPAN MENISCAL REPAIR 12DEG
• Type of Device: SOFT-TISSUE MENISCAL REPAIR ANCHOR, BIOABSORBABLE
• 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 Key: 7149018
• MDR Text Key: 96234210
• Report Number: 1221934-2017-50112
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150209
• 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,Followup,Followup,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228141
• Device Lot Number: L328646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1