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 2018-09-03 for OMNISPAN MENISCAL APPLIER 228143 manufactured by Depuy Mitek Llc Us.
[119652188]
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. A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot released to distribution. 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). 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
[119652409]
This is report 2 of 3 for the same event. It was reported by the sales rep that during a meniscal repair, it was observed that the customer's omnispan applier and two of their omnispan meniscal repair system, 12 degree needle, did not deploy correctly. The sales rep reported that when the surgeon had depressed the first grey trigger about half way, both implants fired together. The sales rep reported this was caught before the implants were actually implanted so they did not have to be removed. The surgeon completed the procedure with another two implants and a new applier with no patient consequences. There was a five minute delay in the procedure. The customer already discarded the complaint devices. 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 | 1221934-2018-53158 |
| MDR Report Key | 7840941 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-03 |
| Date of Report | 2014-12-01 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2014-12-01 |
| Device Manufacturer Date | 2014-07-14 |
| Date Added to Maude | 2018-09-03 |
| 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 | 2018-09-03 |
| Catalog Number | 228143 |
| Lot Number | 3788950 |
| Device Expiration Date | 2017-04-01 |
| 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 | 2018-09-03 |