MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-02 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[140608443]
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. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140608444]
It was reported by the affiliate via email that during an unknown procedure the first implant was positioned correctly in the applicator, but when the doctor used the correct technique (using a malleable hemicanuka) after having crossed the meniscus, the implant would not discharge from the gun despite having repeatedly pressing the trigger. The second implant was positioned correctly in the applicator, but when the doctor used the correct technique (using a malleable hemicanuka) after having crossed the meniscus and fired the first implant, when positioning the second implant a few millimeters, every system came out of the applicator. The surgeon did not want to continue hurting the meniscus with meniscal suture and so chose to do a meniscectomy instead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56733 |
| MDR Report Key | 8473093 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2017-08-22 |
| Date Added to Maude | 2019-04-02 |
| 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 | 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 DEPLOYMENT GUN |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2019-04-02 |
| Catalog Number | 228143 |
| Lot Number | L502531 |
| 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 | 2019-04-02 |