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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE

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CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/21/2020
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand NameQUATTRO SUTURE PASSER NEEDLE
Type of DeviceNEEDLE
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
101
scottsdale AZ 85260
Manufacturer (Section G)
CAYENNE MEDICAL
16597 n 92nd street
101
scottsdale AZ 85260
Manufacturer Contact
shima hashemian
16597 n 92nd street
101
scottsdale, AZ 85260
4805023661
MDR Report Key9860770
MDR Text Key187998322
Report Number3006108336-2020-00005
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2022
Device Model NumberN/A
Device Catalogue NumberCM-9011
Device Lot Number70418-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/20/2020 Patient Sequence Number: 1
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