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 2019-01-15 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[133966920]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4) - incomplete. The exp date is currently unavailable. Investigation summary: the complaint device was received and evaluated. The applier was received with one needle stuck in the applier. The silicon tube on the needle was bounded up and pushed towards the proximal end of the needle. The needle had to be forced out of the gun. Once the needle was removed, the loading and deployment rods were inspected and no anomalies were found. The needle attachment key feature had no anomalies. When tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device. The reported failure could have been caused if the user over-penetrated the needle during usage. When the needle is over-penetrated, result in a lot of needle length behind the meniscus, the silicone and implants can get? Bound up? , the implants may be shifted out of place, and silicone can develop prominent ridges that can catch on tissue and fat pad? All of which could lead to difficulty in deployment. The location of the silicon tube and how it was bound up, confirms this root cause, which is considered a user technique error. Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution. Therefore, at this point in time, based on the overall complaint rate for this failure mode, 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 (b)(4), lot 3892749 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
[133966921]
This is report 1 of 3 for the same event. It was reported by the affiliate in (b)(6) that after the beginning of the meniscus repair surgery, it was observed that the applicator did not fire correctly. According to the reporter, the needle has been changed and a new needle has been used. It was further reported that the same problem appeared with the second needle. A new applicator was then used and no further problems. Therefore the problem seems to be within the applicator. All were used within one surgery. 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 | 1221934-2018-51994 |
| MDR Report Key | 8249031 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-15 |
| Date of Report | 2016-05-12 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-05-12 |
| Date Added to Maude | 2019-01-15 |
| 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 | 2019-01-15 |
| Returned To Mfg | 2016-10-18 |
| Catalog Number | 228143 |
| Lot Number | 3892749 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-01-15 |