MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for QUATTRO SUTURE PASSER NEEDLE N/A CM-9011 manufactured by Cayenne Medical.
[182519794]
Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted
Patient Sequence No: 1, Text Type: N, H10
[182519795]
It was reported that cm-9011 device fractured during surgery, and the tip might have remained in patient. 30 minutes surgical delay was also reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006108336-2020-00004 |
| MDR Report Key | 9803001 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-01-25 |
| Date Added to Maude | 2020-03-06 |
| 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 | MS SHIMA HASHEMIAN |
| Manufacturer Street | 16597 N 92ND STREET 101 |
| Manufacturer City | SCOTTSDALE AZ 85260 |
| Manufacturer Country | US |
| Manufacturer Postal | 85260 |
| Manufacturer Phone | 4805023661 |
| Manufacturer G1 | CAYENNE MEDICAL |
| Manufacturer Street | 16597 N 92ND STREET 101 |
| Manufacturer City | SCOTTSDALE AZ 85260 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUATTRO SUTURE PASSER NEEDLE |
| Generic Name | NEEDLE |
| Product Code | GAB |
| Date Received | 2020-03-06 |
| Model Number | N/A |
| Catalog Number | CM-9011 |
| Lot Number | 70113-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAYENNE MEDICAL |
| Manufacturer Address | 16597 N 92ND STREET 101 SCOTTSDALE AZ 85260 US 85260 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |