MAUDE Adverse Event Report: CAYENNE MEDICAL LOCK-STITCH PROCEDURE KIT; SUTURE KIT, NON-MEDICATED

Catalog Number	CM-9500
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, then nitinol needle got stuck at the end of the suture passer at extended range and would not go back into the loading area.It was determined that needle fractured off inside passer.Needle tip had to be removed with pliers.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D2b.Device product code gab selected as ovn was not available.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6 the reported even is confirmed as the suture passer was returned with the pin broken.Needle broken is unconfirmed.Visual inspection shows that only the suture passer was returned.The lock-stitch and suture passer needle were not returned.Upon inspection of the suture passer it was noted that the trigger pin weld has broken.Other than some minor wear on the instrument, no other damage is noted.The bottom jaws are conforming to the print.For the needle, 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: LOCK-STITCH PROCEDURE KIT
• Common Device Name: SUTURE KIT, NON-MEDICATED
• 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: 21630369
• Report Number: 3006108336-2025-00008
• Device Sequence Number: 20952187
• Product Code: GAB
• UDI-Device Identifier: 00887868270376
• UDI-Public: (01)00887868270376(17)270521(10)66860671
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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 Catalogue Number: CM-9500
• Device Lot Number: 66860671
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART: CM-9010GT.LOT: 435.
• Patient Sex: Female