MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO SUTURE PASSER NEEDLE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that while performing a rotator cuff surgery, the surgeon wanted to pass the quattro broadband tape (loaded to a medial anchor) from one side of the cuff to the other using the quattro suture passer that is loaded with this needle.Needle broke during the procedure of passing the sutures.We had to open a new needle - with this other needle no problem.
Additional 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.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: QUATTRO SUTURE PASSER NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• MDR Report Key: 11608879
• Report Number: 3006108336-2021-00014
• Device Sequence Number: 4009478
• Product Code: NBH
• UDI-Device Identifier: 00887868270147
• UDI-Public: (01)00887868270147(17)220821(10)71972-1
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: N/A
• Device Catalogue Number: CM-9011
• Device Lot Number: 71972-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1