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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE INSTRUMENT, SPORTS MED

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CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE INSTRUMENT, SPORTS MED Back to Search Results
Catalog Number CM9011
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Report source: foreign - event occurred in (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. 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 approximately two (2) months ago, the needle of the device broke during an acl reconstruction procedure. Surgeon replaced the needle and completed the surgery. Patient did not experience any harm. Attempts have been made and no further information has been provided.
 
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Brand NameQUATTRO SUTURE PASSER NEEDLE
Type of DeviceINSTRUMENT, SPORTS MED
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 Key11149934
MDR Text Key226331251
Report Number3006108336-2021-00003
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCM9011
Device Lot Number71972-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberNI

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