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 2018-11-15 for CORDCUTTER *EA 214646 manufactured by Depuy Mitek Llc Us.
[127354659]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4)-incomplete. The lot number is currently unavailable. Investigation summary: the complaint device is not being returned, it is retained by the customer, therefore unavailable for a physical evaluation. This complaint cannot be confirmed. ? No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. If any additional information is obtained, this complaint will be re-opened to capture that information. At this point in time, no corrective action is required, and no further action is warranted. ? However, depuy synthes 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.
Patient Sequence No: 1, Text Type: N, H10
[127354660]
It was reported by the affiliate in (b)(6) that the stopper on the cordcutter device physically broke. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown but was noted to have occurred in 2018. 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 | 1221934-2018-55316 |
| MDR Report Key | 8073916 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-11-15 |
| 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 | 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 | CORDCUTTER *EA |
| Generic Name | SUTURE CUTTER |
| Product Code | FZT |
| Date Received | 2018-11-15 |
| Catalog Number | 214646 |
| 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 | 2018-11-15 |