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

Model Number	CTX-A004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a meniscus repair surgery, when the cartridge was replaced, the axis that moves the upper jaw of the novostitch broke into pieces and could not be manipulated.Surgery was resumed without delay, using a back-up device instead.No further complications were reported.
Additional Manufacturer Narrative
Corrected data: d3 and g1: manufacturing site name and address.This report was inadvertently submitted under manufacturer report number (b)(4).Correct manufacturer report number is (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 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 the linkage to the upper jaw is broken.A functional evaluation revealed pass stitch and lower jaw function properly.The upper jaw lever does not actuate due to broken linkage.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, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• 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: 15481502
• Report Number: 1643264-2022-00347
• Device Sequence Number: 6952154
• Product Code: GAT
• UDI-Device Identifier: 00853541006051
• UDI-Public: 00853541006051
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

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: 09/05/2023
• Device Model Number: CTX-A004
• Device Catalogue Number: CTX-A004
• Device Lot Number: M210192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 12/14/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 11/08/2022; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown