MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-25 for ARTHRO KNOT MANIP FULL *EA 214615 manufactured by Depuy Mitek Llc Us.
[124966537]
(b)(3)-incomplete. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[124966538]
It was reported by the affiliate in (b)(6) that during a right arthroscopic posterior labral repair, when the surgeon was using knot pusher he noted the suture broke prematurely and stated that there was a small cut in the tip of the knot pusher, causing the suture to break. Surgeon was able to salvage suture and re-tie. It was reported that for the remainder of the case, the surgeon used an alternative knot pusher 210835 without incident. It was reported that there was five minute delay to procedure. It was reported that the patient's status post-surgery was stable. 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 | 1221934-2018-55030 |
| MDR Report Key | 8004242 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-25 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-10-25 |
| 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 |
| 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 | ARTHRO KNOT MANIP FULL *EA |
| Generic Name | ARTHROSCOPIC SUTURING DEVICE |
| Product Code | HCF |
| Date Received | 2018-10-25 |
| Catalog Number | 214615 |
| 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 | 2018-10-25 |