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 2019-01-10 for ARTHRO KNOT MANIP FULL *EA 214615 manufactured by Depuy Mitek Llc Us.
[132804515]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4)-incomplete. The lot number is currently unavailable. The complaint device is not being returned, therefore is unavailable for a physical evaluation. Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system. Therefore, we cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode. At this point in time, no corrective action is required and no further action is warranted. This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. 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
[132804516]
This is report 2 of 3 for the same event. It was reported by the sales rep that during an unspecified surgical procedure of the shoulder, it was observed that the customer's healix awl broke mid-shaft when prepping the bone tunnel while in use with two knot manipulators full loop devices that were cutting suture. The sales rep confirmed that nothing broke or fell inside the patient's joint space. The surgeon completed the procedure with another like devices with no patient consequences. There was a nine minute delay reported to complete the procedure. The sales rep reported that the customer did use fiberwire. The sales rep could not provide the lot numbers for the devices but reported that they were all over four years old and had been heavily used. 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 | 1221934-2018-51620 |
| MDR Report Key | 8237521 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-10 |
| Date of Report | 2016-03-21 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2019-01-10 |
| 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 | ARTHRO KNOT MANIP FULL *EA |
| Generic Name | ARTHROSCOPIC SUTURING DEVICE |
| Product Code | HCF |
| Date Received | 2019-01-10 |
| Catalog Number | 214615 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-10 |