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

Catalog Number CM-9011

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign country: 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 three (3) weeks ago, the needle of the device broke during an acl reconstruction procedure.Patient retained the broken piece.Surgeon replaced the needle and completed the surgery.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: QUATTRO SUTURE PASSER NEEDLE
• Type of Device: INSTRUMENT, SPORTS MED
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• MDR Report Key: 11149901
• MDR Text Key: 226238199
• Report Number: 3006108336-2021-00004
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2022
• Device Catalogue Number: CM-9011
• Device Lot Number: 71972-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other