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 2019-01-22 for CORDCUTTER *EA 214646 manufactured by Depuy Mitek Llc Us.
[133940945]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The lot number is currently unavailable. The complaint device was received and inspected visually and functionally. Visually, it was observed that the handle of the cord cutter is slightly bent inwards; indicating device mishandling. Functionally, this device was tested on orthocord suture for 10 times and the device performs as intended with no fault found. A root cause for the reported failure cannot be determined at this time. Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution. Based on the overall complaint rate for this device, at this point in time, 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. This report is being filed from the etq 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
[133940946]
This is report 2 of 2 for the same event. It was reported by the sales rep that the customer's healix advanced knotless peek anchor 475 mm and cord cutter failed during a shoulder arthroscopy. The pull tab to load broke, wings open on anchor, could not use to implant. The safety trigger on the cord cutter was not working due to the spring being bent or broke. Case completed using other like devices. The cord cutter will be returned only as the anchor was discarded by the facility. 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 | 1221934-2018-53051 |
| MDR Report Key | 8268310 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-22 |
| Date of Report | 2016-12-07 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-01-22 |
| 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 | 3 |
| Brand Name | CORDCUTTER *EA |
| Generic Name | SUTURE CUTTER |
| Product Code | FZT |
| Date Received | 2019-01-22 |
| Returned To Mfg | 2017-02-03 |
| Catalog Number | 214646 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-01-22 |