MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for QUATTRO SUTURE PASSER NEEDLE N/A CM-9011 manufactured by Cayenne Medical.
[187998322]
Customer has indicated that the product will not be returned to zimmer biomet for investigation because device was scrapped by customer. Dhr was reviewed and no discrepancies were found. The complaint was not confirmed. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[187998323]
It was reported that during a rotator cuff repair surgery, a suture passer needle cm-9011 fractured. The fractured piece was not located inside or outside the patient and it could have remained inside the patient. 45 minute surgical delay was reported for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006108336-2020-00005 |
| MDR Report Key | 9860770 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-04-19 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | N/A |
| Catalog Number | CM-9011 |
| Lot Number | 70418-1 |
| 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 | 2020-03-20 |