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

Catalog Number 228143

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).Investigation summary: the complaint device was received and evaluated.Initial visual observation of the device revealed the deployment slider appeared to be bent at the distal tip.The gray trigger could be triggered properly and the deployment slider protrudes out fully.The red trigger rod was present and functioned normally.The bent deployment slider prevented the needle from loading onto the applier, this complaint is confirmed.We cannot determine a definitive root cause for it being bent.Possible root causes could be; excessive force being applied to the needle, or improper assembly of the needle onto the applier resulted in the bend.A manufacturing record evaluation was performed for the finished device, 5l45154, number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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.Device history lot: a manufacturing record evaluation was performed for the finished device, 5l45154, number, and no non-conformances were identified.

Event Description

It was reported by the affiliate in (b)(6) that during an ligamentoplasty (knee arthroscopy repair) procedure, it was observed that the implant did not hold on to the meniscal deployment gun preoperatively.According to the report, the impact on the meniscus was not possible to be made and the two sutures were not able to implanted.There was an unspecified surgical delay but the procedure was completed by using another gun.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.During in-house engineering evaluation, it was determined that the deployment slider appeared to be bent at the distal tip.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 9580379
• MDR Text Key: 206735949
• Report Number: 1221934-2020-00135
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Catalogue Number: 228143
• Device Lot Number: 5L45154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/13/2020
• 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