MAUDE Adverse Event Report: CAYENNE MEDICAL SURELOCK ALL-SUTURE ANCHOR; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery, the suture didn't slide after the surgeon implanted the anchor of this complaint product into the burr hole.The anchor was left in the patient's body, but not serving its intended purpose, the sutures were removed.Another anchor was used in a different location to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign : japan product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event cannot be confirmed.Visual inspection of the returned device identified that the inserter was returned.The knob rotated both ways and the inserter shaft were extended and retracted.No anchor was returned as it was left implanted device history records were reviewed and no discrepancies related to the reported event were found.Medical records were not provided.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.

• Brand Name: SURELOCK ALL-SUTURE ANCHOR
• 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: 19182496
• Report Number: 3006108336-2024-00013
• Device Sequence Number: 20580287
• Product Code: MBI
• UDI-Device Identifier: 00887868270482
• UDI-Public: (01)00887868270482(17)250811(10)65582926
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/02/2024

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 Expiration Date: 08/11/2025
• Device Model Number: N/A
• Device Catalogue Number: CM-9614F
• Device Lot Number: 65582926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown