MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-02-19 for MENISCAL R/S APPLIER *EA 228000 manufactured by Depuy Mitek Llc Us.
[136605689]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: evaluation statement- the complaint device is not being returned, therefore is unavailable for a physical evaluation. A batch record review 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 mitek complaints system revealed no other complaints of any kind 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. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[136605690]
The sales rep reported the customer's meniscal applier would not deploy their rapidloc 12 degree needle far enough into the meniscus during a meniscal repair. This caused the anchor to jam in the device and not deploy correctly. The surgeon could no longer pull the trigger for the applier once this happened. He used a different method to complete the procedure and there was a 10 minute delay. The complaint devices were already discarded by the customer. The sales rep stated it was a (b)(4) year old female with preexisting medical conditions. No further information could be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56426 |
| MDR Report Key | 8351029 |
| Report Source | OTHER |
| Date Received | 2019-02-19 |
| Date of Report | 2013-06-11 |
| Date of Event | 2013-06-11 |
| Date Mfgr Received | 2013-06-11 |
| Device Manufacturer Date | 2011-02-15 |
| Date Added to Maude | 2019-02-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 6103142063 |
| 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 R/S APPLIER *EA |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2019-02-19 |
| Catalog Number | 228000 |
| Lot Number | 3504583 |
| Device Expiration Date | 2016-02-01 |
| 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 | 2019-02-19 |