MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-10-10 for ARTHRO KNOT MANIP FULL *EA 214615 manufactured by Depuy Mitek.
[123205529]
(b)(6). Udi: incomplete (b)(4). The expiration date and lot/serial number are currently unavailable. As of this date, the device has not been returned for evaluation. If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[123205530]
It was reported by the affiliate via e-mail that during a rotator cuff repair, when typing down sutures using the knot pusher, it was observed that the suture broke half way up the suture. It was reported that the surgeon noticed a sharp scratch/groove on the internal tip of the knot pusher. An alternate knot pusher was used for remainder of the case. There was no delay to procedure and no adverse effect on the patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-54899 |
| MDR Report Key | 7951144 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-10-10 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-10-10 |
| 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 | MRS. KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY MITEK |
| 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 | INSTRUMENT, LIGATURE PASSING AND KNOT TYING |
| Product Code | HCF |
| Date Received | 2018-10-10 |
| Returned To Mfg | 2018-11-15 |
| Catalog Number | 214615 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-10 |