MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for EXPRESSEW III W/O HOOK 214140 manufactured by Depuy Mitek Llc Us.
[135940695]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[135940696]
It was reported by the sales rep via phone that during a rotator cuff repair procedure the customer's expressew iii without hook jaw was loose. The sales rep stated that when the jaw bit down on the tissue, it would not hold. The sales rep stated that the surgeon was not grabbing too much tissue. The case was completed with another like-device with no patient harm or delay. The sales rep was not present and could not provide any additional information. The availability of the device is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56332 |
| MDR Report Key | 8307552 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-01-18 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2017-04-06 |
| Date Added to Maude | 2019-02-05 |
| 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 | 6103142063 |
| 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 | 0 |
| Brand Name | EXPRESSEW III W/O HOOK |
| Generic Name | SUTURE/NEEDLE PASSER, REUSABLE |
| Product Code | LHX |
| Date Received | 2019-02-05 |
| Catalog Number | 214140 |
| 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 | 2019-02-05 |