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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 04/12/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign: (b)(6). Customer has not indicated that the product will be returned to zimmer biomet for investigation. If device returns or once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during a right shoulder arthroscopy cuff repair operation, the hook end (tip end) from the quattro suture passer was missing. Attempts were made to find the missing tip but were not found, it was reported to not be in the joint and most likely to be the cuff, soft tissue or outside of the patient. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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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 Key12017310
MDR Text Key256738557
Report Number3006108336-2021-00025
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCM-9011
Device Lot Number75957-1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2020
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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