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 2019-01-24 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[135192800]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The complaint device is not being returned, therefore unavailable for a physical evaluation. A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. We cannot discern a root cause for the reported failure mode. At this point in time, no corrective action is required and no further action is warranted. This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. However, depuy 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
[135192801]
This is report 1 of 2 for the same event. It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the meniscal deployment gun device and omnispan meniscal repair 12deg device did not work together. According to the reporter, the applicator did not work so a new applicator and needle had to be opened. It was reported that the issue was with the first implant and the second. It was reported that both implants were removed by cutting the sutures. It was reported that there was no tissue damage. It was reported that the procedure was completed with same like product from another company with a five minute delay. It was unknown if the surgeon used the same location as the original implant but the reporter speculated that it was a different location. 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 | 1221934-2018-53755 |
| MDR Report Key | 8275644 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-24 |
| Date of Report | 2017-03-30 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2017-01-20 |
| Date Added to Maude | 2019-01-24 |
| 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 | 2019-01-24 |
| Catalog Number | 228143 |
| Lot Number | L252327 |
| Device Expiration Date | 2019-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-24 |