MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-04-04 for CORDCUTTER *EA 214646 manufactured by Depuy Mitek Llc Us.
[141077691]
(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)-incomplete. The lot number is unknown.
Patient Sequence No: 1, Text Type: N, H10
[141077692]
It was reported by the affiliate that during the surgery the wire cutter of the shoulder box was broken. There was neither patient harm nor surgical delay was indicated. Due to the breakage the cord cutter did not cut the wires of the anchors used. They have used another device to cut the wires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56766 |
| MDR Report Key | 8484448 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-04-04 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-04-04 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| 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 | 2019-04-04 |
| Catalog Number | 214646 |
| Lot Number | UNKNOWN |
| Device Expiration Date | 2018-06-30 |
| 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 | 2019-04-04 |