MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO LINK ANCHOR 5.5MM; 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	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign : india.Customer has indicated that the product is in process of being 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 surgery that the anchor screw has broken during insertion in shoulder.Another 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.The following sections were updated/corrected.Updated: g4; h2; h3; h6.Visual examination of the provided pictures identified anchor fractured near the tip and the inserter tip is bent at the same location as the fracture.Photos do not allow for any further visual evaluation.No product 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.
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.The following sections were updated/corrected.H6 - updated to remove type of investigation "4114 - device not returned".Visual examination of the returned product identified that the anchor is fractured.Most of the anchor remains on the inserter, but all pieces of the anchor were returned for evaluation.The inserter prongs are bent at nearly a 45-degree angle and are pushed together.The anchor fracture corresponds to the bend in the inserter prongs.The inserter prongs can be extended and retracted using the adjustment knob.Medical records were not provided.Device history records were reviewed and no discrepancies related to the reported event were found.Previous root cause remains unchanged.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 5.5MM
• 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: 14938250
• Report Number: 3006108336-2022-00021
• Device Sequence Number: 4557496
• Product Code: MBI
• UDI-Device Identifier: 00887868270222
• UDI-Public: (01)00887868270222(17)261015(10)65289188
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 10/20/2022

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-9155
• Device Lot Number: 65289188
• 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: 06/10/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 10/13/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/25/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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
• Patient Age: 37 YR
• Patient Sex: Female