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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER GT

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CAYENNE MEDICAL QUATTRO SUTURE PASSER GT Back to Search Results
Model Number N/A
Device Problems Device Damaged Prior to Use (2284); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2020
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
Customer has not returned the device for investigation despite three attempts.Complaint was not confirmed, and the root cause of this event cannot be determined.Dhr and complaint history for lot number were unable to reviewed since the lot number was not provided.Complaint history was reviewed using catalog number and reported complaint categories, and it was determined no capa is required.Dfmea was investigated for the failure mode, and it is captured.Cayenne will continue to monitor for future events.H3 other text : device not returned.
 
Event Description
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.
 
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Brand Name
QUATTRO SUTURE PASSER GT
Type of Device
SUTURE PASSER
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
101
scottsdale AZ 85260
MDR Report Key9886169
MDR Text Key186565273
Report Number3006108336-2020-00006
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberCM-9010GT
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/28/2020
Initial Date FDA Received03/26/2020
Supplement Dates Manufacturer Received02/28/2020
Supplement Dates FDA Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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