MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-30 for OMNISPAN MENISCAL APPLIER 228143 manufactured by Depuy Mitek Llc Us.
[119158565]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation. Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system. Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode. At this point in time, no corrective action is required and no further action is warranted. However, depuy 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. (b)(4) - incomplete. The lot number is currently unavailable; therefore, the device manufacture date is unavailable. This report is being filed from the remetrex 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
[119158566]
This is report 1 of 2 for the same event. It was reported by the sales rep that during a meniscal repair, it was observed that the customer's omnispan meniscal applier jammed on the third implant, the omnispan meniscal repair system, 0 degree needle, as it was being inserted into the meniscus. The surgeon had implanted the first backstop successfully penetrating the meniscus, then press the red, then second gray trigger when it jammed. The surgeon completely removed this implant but the needle became jammed inside the gun and could not be removed. The surgeon completed the procedure with another gun and with two additional implants with no patient consequences or delay. The sales rep reported that the surgeon is very experienced with these devices. The sales rep reported that there was no bunching of the silicone that he was aware of when the gun jammed. 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 | 1221934-2018-53815 |
| MDR Report Key | 7832114 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-30 |
| Date of Report | 2014-04-30 |
| Date of Event | 2014-04-30 |
| Date Mfgr Received | 2014-04-30 |
| Date Added to Maude | 2018-08-30 |
| 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 | OMNISPAN MENISCAL APPLIER |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2018-08-30 |
| Catalog Number | 228143 |
| Lot Number | UNK |
| 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 | 2018-08-30 |