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 2019-01-16 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[133954975]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). The complaint device was received and evaluated. Visual observation of the device reveals the pusher rod was bent downward. This is possibly due to forced loading/unloading of the needle. There were a lot of tissue accumulation on the loading rod (red trigger), but no damage. When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device. It cannot be determined at what point the pusher rod was bent. This could have possibly caused the misfiring. A definitive root cause cannot be determined at this point from the details provided. A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution. Based on the overall complaint rate, at this point in time, no further action is warranted. However, 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. A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. This report is being filed from the (b)(4) 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
[133954976]
This is report 1 of 2 for the same event. It was reported by the affiliate in (b)(6) that during mensical repair surgical procedure, it was observed that when the first point of the suture was placed, the suture fired properly and when shooting with the red trigger to advance the next point, the second point of the suture did not advance. There was no delay in the procedure which was completed by the surgeon using another device. The needle was loaded in the correct orientation. The surgeon used the same location for the second implant. The red trigger of the gun did not move when depressed and the there surgery group did hear a 'click'. 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 | 1221934-2018-50863 |
| MDR Report Key | 8252293 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-16 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-10-28 |
| Date Mfgr Received | 2015-10-29 |
| Device Manufacturer Date | 2015-04-15 |
| Date Added to Maude | 2019-01-16 |
| 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 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| 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 | 2019-01-16 |
| Returned To Mfg | 2015-11-13 |
| Catalog Number | 228143 |
| Lot Number | 3837471 |
| Device Expiration Date | 2018-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-01-16 |