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 2019-01-24 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[134887329]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). The complaint device was received and evaluated. Visual observation reveals that the lower pusher rod on the applier was found bent at the distal tip which makes it difficult to deploy the implant in the needle. When tested for its functionality, the grey trigger was rough to operate and its getting stuck in the middle. When red trigger was tested, it functions as intended. This complaint can be confirmed. The root cause for this failure would typical be application of an excess load to the needle when the lower push rod is at deployed condition. This failure can be attributed to device misuse. Further, a review into the depuy synthes mitek complaints system revealed no other complaint for 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. A non-conformance search was performed for this product code 228143, lot 3873093 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 (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
[134887330]
This is report 1 of 2 for the same event. It was reported by the affiliate in (b)(6) that during a meniscal repair surgical procedure with meniscal suture, it was observed that the omnispan meniscal repair 27deg and meniscal deployment gun did not work properly while in use together. According to the reporter, both devices did not work accordingly to their purposes. It was further reported that during the surgery performed, it was expected two shots of using this device but the device could not performed the second shot (carried out). It was reported that it might have been that the pistol being jammed. It was reported that the first implant was removed and did not cause tissue damage. It was reported that the first implant did penetrate the meniscus. It was reported that the surgeon used the same location to complete the procedure. It was reported that there were no implants used as the surgeon used another suture. It was reported that the procedure was completed with another suture. 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 | 1221934-2019-56103 |
| MDR Report Key | 8274441 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-24 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-01-24 |
| 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 | 2019-01-24 |
| Returned To Mfg | 2017-04-19 |
| Catalog Number | 228143 |
| Lot Number | 3873093 |
| Device Expiration Date | 2018-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-01-24 |