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

Catalog Number	CM-9145SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial tissue repair procedure, the anchor fractured during implantation.All parts were recovered and there were no reported adverse events as a result of the malfunction.A second device was used to complete the procedure.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).A2: year of birth: 1988 g2: foreign: (b)(6).The product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of provided pictures identified that the anchor is broken on the inserter with biological debris.As no product was returned, further visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was confirmed by review of provided photograph.If any further information is found 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 or Problem Description
No further event information at time of this report.

• Brand Name: QUATTRO LINK ANCHOR 4.5MM SP
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 18120648
• Report Number: 3006108336-2023-00032
• Device Sequence Number: 7540602
• Product Code: MBI
• UDI-Device Identifier: 00887868270208
• UDI-Public: (01)00887868270208(17)270915(10)65582823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/27/2024

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 Catalogue Number: CM-9145SP
• Device Lot Number: 65582823
• Was Device Available for Evaluation?: No
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 80 KG