MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for CORDCUTTER *EA 214646 manufactured by Depuy Mitek Llc Us.
[133963119]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). Investigation summary: the complaint device was received and evaluated. Visual inspection revealed the device was extremely worn and the handle was discolored. The entire inner shaft which protrudes out the distal end of the outer shaft was missing, confirming this complaint. This failure can be attributed to field wear and tear. The lot number of this reusable device indicates that it is about seven years old and has possibly seen heavy use in the field. Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution. At this time, no corrective action is required and no further action is warranted. A device history 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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field. This report is being filed from the (b)(4) 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
[133963120]
It was reported by the sales rep that the piece that cuts broke on the customer's cord cutter during a rotator cuff procedure. According to the reporter, it was broken as it was picked up from tray. The case was completed with another like device. There were no adverse patient consequences or delay. The device will be returned for evaluation. 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 | 1221934-2019-56092 |
| MDR Report Key | 8270909 |
| Date Received | 2019-01-23 |
| Date of Report | 2017-01-30 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-01-30 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2019-01-23 |
| 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 | 6013142063 |
| 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 | 0 |
| Brand Name | CORDCUTTER *EA |
| Generic Name | SUTURE CUTTER |
| Product Code | FZT |
| Date Received | 2019-01-23 |
| Returned To Mfg | 2017-03-21 |
| Catalog Number | 214646 |
| Lot Number | 09A1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-01-23 |