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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part # cm-9145sp quattro link anchor 4.5mm sp lot # 65472625.Part # cm-9129 quattro link anchor 2.9mm lot # 65319443, part # cm-9300st 2.9mm gl drill lot # 65354710, part # cm-0322 brdband 2pk:bk/bl+bk lot # 20072125, part # 904055 ez pass 30 degree right lot # 489880, part # 904055 ez pass 30 degree right lot # 417750, part # cm-9255bg quattro x anchor 5.5 bb tapens lot # 78826-2, part # cm-0322 brdband 2pk:bk/bl+bk lot # 21090124, part # cm-9011 quattro suture passer needle lot # 65223488, part # cm-9145sp quattro link anchor 4.5mm sp lot # 65390524.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown.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 during surgery on the right side of the patient, while malleating in the anchor, the tip of the anchor broke in half.Anchor was removed and additional anchor was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
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.Visual examination of the provided pictures show that the anchor is fractured at the indicator line and remains in place at the tip of the inserter.The other broken portion of the anchor cannot be seen in the provided photos.The inserter prongs are also bent at the tip.As no device was returned, further 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: 15750943
• Report Number: 3006108336-2022-00033
• Device Sequence Number: 14182577
• Product Code: MBI
• UDI-Device Identifier: 00887868270161
• UDI-Public: (01)00887868270161(17)261210(10)65319443
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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-9129
• Device Lot Number: 65319443
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Male