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 2018-09-13 for MENISCAL APPLIER, OMNISPAN 228143 manufactured by Depuy Mitek Llc Us.
[120260765]
(b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4)-incomplete. Lot number is currently unavailable.
Patient Sequence No: 1, Text Type: N, H10
[120260766]
It was reported that meniscal deployment gun and 27 degree needle didn't work in operation. The deployment gun didn't release normally. Operating surgeon was experienced, who knows how to use the device. There was a delay of the surgery for 5 minutes. The issue was detected during the procedure. The procedure was able to be completed and there was no patient impact. The instrument and implant were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-54641 |
| MDR Report Key | 7874434 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-13 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2018-01-29 |
| Date Added to Maude | 2018-09-13 |
| 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 APPLIER, OMNISPAN |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2018-09-13 |
| Returned To Mfg | 2018-11-09 |
| Catalog Number | 228143 |
| Lot Number | L746168 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-13 |