MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for MENISCAL R/S APPLIER *EA 228000 manufactured by Depuy Mitek Llc Us.
[134575683]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint devices are not being returned, therefore unavailable for physical evaluations. A review into the depuy synthes mitek complaints system revealed no other complaints for these 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 synthes mitek will continue to track any related complaints within these devices' families as a means of monitoring the extent with which this complaint is observed in the field. No nonconformances were identified for this product code 228000 - lot # 3820315 combination. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134575684]
It was reported that the meniscal applier with the rapidloc 2/0 paracryl 27 degree needle handle broke during a knee scope procedure. There was no debris left in the patient and where the device broke stays outside the patient. The case was completed with a back up device and another needle using the same bone hole. There were no patient consequences but there was a minute delay in the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56278 |
| MDR Report Key | 8290558 |
| Date Received | 2019-01-30 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-07-06 |
| Date Mfgr Received | 2016-07-06 |
| Device Manufacturer Date | 2014-06-26 |
| Date Added to Maude | 2019-01-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 5089776860 |
| Manufacturer G1 | DEPUY MITEK |
| 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 R/S APPLIER *EA |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2019-01-30 |
| Catalog Number | 228000 |
| Lot Number | 3820315 |
| 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 | 2019-01-30 |