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 2018-09-07 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[119940390]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). The lot number is not currently available.
Patient Sequence No: 1, Text Type: N, H10
[119940391]
If was reported by an affiliate, in the hospital there have been false tripping with omnispan. The morning of the event, seams could not be set as desired. Omni meniscal repair 12-deg (p/n 228141) and omnispan meniscal deployment gun (p/n 228143) were used. With two needles, both peek buttons came out at the same time, with one needle, the button did not come out at all. A similar device was used to complete the surgery, and no surgical intervention is planned. The user was very experienced. That's why you can not speak of a user error here. Both products were discarded thus no lot number is available. No patient harm reported. Surgical delay of 5 minutes. No complaint devices remained in the patient after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-54587 |
| MDR Report Key | 7855376 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-07 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-08-13 |
| Date Mfgr Received | 2018-09-11 |
| Date Added to Maude | 2018-09-07 |
| 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 | MRS. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| 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 | 2018-09-07 |
| Catalog Number | 228143 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-09-07 |