MAUDE Adverse Event Report: CETERIX ORTHOPAEDICS, INC NOVOSTITCH PRO MENISCAL RPR SYS 0; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	CTX-A004
Medical Device Problem Codes	Break (1069); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: corrected information in h6 (health effect - impact code).
Event or Problem Description
It was reported that, during an arthroscopic procedure, the novostitch could not fire properly.Surgery was completed with a back-up device instead.There was a surgical delay of approximately 2 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The device was returned with the articulation bar for the top jaw fractured.There is biological debris on the device and the lower jaw is intact.A functional evaluation found the device cannot perform as designed due to physical damage to the device.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: NOVOSTITCH PRO MENISCAL RPR SYS 0
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): CETERIX ORTHOPAEDICS, INC; 6500 kaiser dr ste 120; fremont CA 94555
• Manufacturer (Section G): CETERIX ORTHOPAEDICS, INC; 6500 kaiser dr ste 120; fremont CA 94555
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20152770
• Report Number: 3009131204-2024-00010
• Device Sequence Number: 8259232
• Product Code: GAT
• UDI-Device Identifier: 00853541006051
• UDI-Public: 853541006051
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K181772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 06/07/2025
• Device Catalogue Number: CTX-A004
• Device Lot Number: M230087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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
• Patient Sex: Unknown