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 2020-03-26 for QUATTRO SUTURE PASSER N/A CM-9010 manufactured by Cayenne Medical.
[186565273]
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
[186565274]
It was reported that suture passer malfunctioned during surgery, damaging two suture passer needles and cutting the sutures. 45 minutes surgical delay was reported. No other patient harm was reported
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006108336-2020-00006 |
| MDR Report Key | 9886169 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| 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 |
| Generic Name | SUTURE PASSER |
| Product Code | NBH |
| Date Received | 2020-03-26 |
| Model Number | N/A |
| Catalog Number | CM-9010 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-26 |