MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 4.5MM SP; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign : poland.Customer has indicated that the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the anchor fractured when hammered into the bone.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned device shows that the anchor and snare loop were not returned.The knob operates as intended moving the tip in and out.There is no noted damage to the device, and item and lot numbers are not confirmed as they are not etched on the parts.As anchor was not returned and no pictures provided; further visual and dimensional evaluations of the anchor could not be performed.Medical records were not provided.Device history records were reviewed and no discrepancies related to the reported event were found.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: QUATTRO LINK ANCHOR 4.5MM SP
• Common Device Name: FASTENER, FIXATION
• 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: jennifer rapsavage ; 56 e. bell dr; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17435309
• Report Number: 3006108336-2023-00026
• Device Sequence Number: 20518699
• Product Code: MBI
• UDI-Device Identifier: 00887868270208
• UDI-Public: (01)00887868270208(17)270804(10)65536897
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K122314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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 Model Number: N/A
• Device Catalogue Number: CM-9145SP
• Device Lot Number: 65536897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Age: 51 YR
• Patient Sex: Male