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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE NEEDLE, SUTURING

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CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE NEEDLE, SUTURING Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: part cm-9010gt quattro suture passer gt lot 1573. Part cm-9145sp quattro link anchor 4. 5mm sp lot 77244-3. Report source: foreign: (b)(6). Visual examination of the returned product identified the suture passer was returned with minimal signs of use. The shaft and jaws show no signs of damage. The handle and trigger mechanisms function smoothly and close the jaws completely. No other damage observed. No needle was returned or pictures provided; visual and dimensional evaluations could not be performed. Medical records were not provided. Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event. Root cause was unable to be determined. 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 the quattro suture passer needle got stuck and broke inside of the suture passer during the surgery. The procedure was successfully finished with another device. There was no impact on patient. No further event information available at the time of this report.
 
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Brand NameQUATTRO SUTURE PASSER NEEDLE
Type of DeviceNEEDLE, SUTURING
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer (Section G)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer Contact
shima hashemian
16597 n 92nd street
scottsdale, AZ 85260
4805023661
MDR Report Key13111330
MDR Text Key290074147
Report Number3006108336-2021-00057
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/27/2021
Device Model NumberN/A
Device Catalogue NumberCM-9011
Device Lot Number69355-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2018
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

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