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 2019-01-21 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[134328110]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (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 (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
[134328111]
It was reported by the affiliate in (b)(6) that during an meniscal repair surgical procedure, it was observed that the needle was stuck on the meniscal deployment gun and could not be removed. According to the reporter, the event occurred while trying to remove the first needle to reload it with a second. It was further reported that the nurse had to break the needle off as it had jammed. There was no delay in the surgical procedure as an identical spare device was used to complete the 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 | 1221934-2019-56057 |
| MDR Report Key | 8263732 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-21 |
| Date of Report | 2016-08-26 |
| Date of Event | 2016-08-26 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2015-08-20 |
| Date Added to Maude | 2019-01-21 |
| 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 | 2019-01-21 |
| Catalog Number | 228143 |
| Lot Number | 3860304 |
| Device Expiration Date | 2018-05-31 |
| 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 | 2019-01-21 |