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 2018-10-29 for CORDCUTTER *EA 214646 manufactured by Depuy Mitek Llc Us.
[125289663]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). Investigation summary: the complaint device was received and inspected. The complaint cannot be confirmed. Visual observation revealed light nicks and marks at the distal tip, and when the cutter rod was removed some debris was present along the surface of the rod. When tested for its functionality, it was fully functional, but the device cutter could not be returned to the original position easily. It is possible that debris has built up inside the device after being reused multiple times and not cleaned properly. However, given the information provided we cannot discern a definitive root cause for the reported failure. A device history record (dhr) 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. At this point, 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
[125289664]
It was reported by the sales rep that during a rotator cuff repair, a cord cutter broke during the procedure. The inner hub inserter piece became stuck and subsequently the handle could not be used. There was a 2 minute delay in the case and no patient consequences. A new cord cutter was opened and the case completed. Patient consequence? No. Is the information being submitted for this complaint all the details that are known/available regarding this event? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-55059 |
| MDR Report Key | 8013772 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-29 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-10-29 |
| 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 | CORDCUTTER *EA |
| Generic Name | SUTURE CUTTER |
| Product Code | FZT |
| Date Received | 2018-10-29 |
| Returned To Mfg | 2018-07-17 |
| Catalog Number | 214646 |
| Lot Number | 15P09 |
| 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 | 2018-10-29 |