MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 2.9MM; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3006108336-2023-00023, 3006108336-2023-00024.It is noted that for these reports, only two out of the three anchors were reported to be retained.All reports are being listed for serious injury as it is unknown which lots were retained.G2 : foreign : japan.The device will not be returned for analysis, however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the surgery for the pectoralis major muscle repair, the anchor of the complaint product was fractured while the surgeon tried to implant it.It was reported that three anchors fractured and two of the three anchors remained in the patient's bone.It was reported as well that the bone quality of the patient was hard.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Adding note for there being an inserter the was fractured and retained along with the anchor fractured and retained.It is noted that it is unknown which lot was fractured and retained.No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It is noted that for these reports, only two out of the three anchors were reported to be retained.All reports are being listed for serious injury as it is unknown which lots were retained.Adding note for there being an inserter the was fractured and retained along with the anchor fractured and retained.It is noted that it is unknown which lot was fractured and retained.No product was returned or pictures provided; visual and dimensional evaluations 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.

• Brand Name: QUATTRO LINK ANCHOR 2.9MM
• 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: 17317345
• Report Number: 3006108336-2023-00025
• Device Sequence Number: 14976295
• Product Code: MBI
• UDI-Device Identifier: 00887868270161
• UDI-Public: (01)00887868270161(17)271110(10)65614205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-9129
• Device Lot Number: 65614205
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown