MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-14 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[133846857]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The lot number is currently unavailable; therefore, the exp date is unavailable. The complaint device is not being returned, therefore unavailable for a physical evaluation. A review into the depuy synthes 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 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. A non-conformance search was performed for this product code 228143, lot 3860947 combination and no non-conformances were identified. No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. If any additional information is obtained, this complaint will be re-opened to capture that information. At this point in time, no corrective action is required, and no further action is warranted. 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
[133846858]
This is report 1 of 2 for the same event. It was reported by the sales rep that during a meniscal repair, it was observed that the coil got stuck when deploying the 2nd implant of the customer's omnispan meniscal repair system with 12 degree needle. The sales rep reported that the coil went under the 2nd implant, got stuck and did not advance it. The surgeon cut the suture between them and left the 1st implant in the meniscus. The surgeon completed the procedure with another like omnispan meniscal applier and another same like implant right adjacent to the original implant. There were no patient consequences or delays reported. The sales rep reported that the surgeon used two more implants to complete the repair and did not feel that the first implant failing caused the plan to be altered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-55995 |
| MDR Report Key | 8245700 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-14 |
| Date of Report | 2016-03-17 |
| Date of Event | 2016-03-17 |
| Date Mfgr Received | 2016-03-17 |
| Date Added to Maude | 2019-01-14 |
| 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 | 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 | 2019-01-14 |
| Catalog Number | 228143 |
| Lot Number | UNK |
| 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 | 2019-01-14 |