MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-28 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[134186221]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). The complaint devices were not returned, therefore unavailable for a physical evaluation. A definitive root cause could not be determined at this time but it is possible that the sleeve was not fully retracted into the device, causing a loose connection. A dhr has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy synthes mitek complaints system revealed 1 dissimilar complaint this lot of devices that were released to distribution. At this point in time, 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 (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
[134186222]
It was reported by the affiliate in (b)(6) that at the moment of meniscus suture of patient, the applicator caught, and lost the suture needle during an unspecified surgical procedure. It was not reported if there was a delay in the surgical procedure of if a 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 | 1221934-2019-56134 |
| MDR Report Key | 8280896 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-28 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-06-28 |
| Device Manufacturer Date | 2014-11-25 |
| Date Added to Maude | 2019-01-28 |
| 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 | 2019-01-28 |
| Catalog Number | 228143 |
| Lot Number | 3863074 |
| Device Expiration Date | 2018-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-28 |