MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO GL2 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	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign: india.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been.
Event or Problem Description
It was reported during shoulder arthroscopy surgery, when attempting to insert the anchor, it broke.Another device was used to complete the procedure, no patient harm was reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported during shoulder arthroscopy surgery, when attempting to insert the anchor, it broke.Another device was used to complete the procedure, no patient harm was reported.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.D10: part # 912031 jgrknt 1.5mm #2 mb sngl 2 mb sngl lot # 2416628; part # 912031 jgrknt 1.5mm #2 mb sngl 2 mb sngl lot # 2392612; part # 912031 jgrknt 1.5mm #2 mb sngl 2 mb sngl lot # 2416628; part # cm-93291 quattro gl anchor 2.9mm lot # 64519-1.Visual examination of the provided pictures identified that the anchor is fractured with the sutures trailing out of the fractured off pieces of the anchor.The remaining part of the anchor is still attached to the inserter.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.

• Brand Name: QUATTRO GL2 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: 14695391
• Report Number: 3006108336-2022-00019
• Device Sequence Number: 6609347
• Product Code: MBI
• UDI-Device Identifier: 00887868270369
• UDI-Public: (01)00887868270369(17)230906(10)68425-2
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K131325
• 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): 08/10/2022

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 Expiration Date: 09/06/2023
• Device Model Number: N/A
• Device Catalogue Number: CM-9329GL2
• Device Lot Number: 68425-2
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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 Sex: Female