MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-10 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[133074563]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The complaint devices were received and tested. Visually, the main pusher rod (gray trigger) on both guns were observed to be bent at the distal tip. This bend in pusher rod is typical of aggressively removing the needle following use. Additionally, the needle was received without the suture attachment and had no anomolies. When tested for its functionality, both devices's grey triggers were rough to operate but still actuated the pusher rod. This complaint could be confirmed and the failure could be attributed to mishandling of the device. Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. At this point, 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. This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[133074564]
This is report 1 of 5 for the same event. It was reported by the affiliate in (b)(6) that during anterior cruciate ligament (acl) reconstruction and meniscal suture surgical procedures, it was observed that the stylet of device would not retract and the trigger would not work after first time firing. The surgeon then changed to a new device to continue but it was reported that the stylet still would not retract and trigger did not work after the first time firing. It was reported that the surgeon changed to a third device to complete the procedure successfully. According to the reporter, it was the grey trigger of the deployment gun that would not work. It was further reported that the surgeon did not over penetrate the meniscus. It was unknown if a new location was used for the implant upon the third attempt. There was no delay during procedure. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-51401 |
| MDR Report Key | 8237002 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-10 |
| Date of Report | 2015-11-23 |
| Date of Event | 2015-11-22 |
| Date Mfgr Received | 2019-01-17 |
| Device Manufacturer Date | 2014-06-16 |
| Date Added to Maude | 2019-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6013142063 |
| Manufacturer G1 | DEPUY MITEK LLC US |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENISCAL DEPLOYMENT GUN |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2015-12-07 |
| Catalog Number | 228143 |
| Lot Number | 3783995 |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |