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

Catalog Number	CTX-A004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an arthroscopic procedure, the novostitch jaw was not opening and closing properly, and it was later discovered that part of the jaw had broken off inside the patient.The small piece was flushed out of the joint.Surgery was completed with a back-up device, resulting in a surgical delay of less than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H3, h6: the reported device was received for evaluation.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 review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review identified similar reported events; however, no distinct trend has been observed for the reported event.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.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Other factors include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that, during an arthroscopic procedure, the novostitch jaw was not opening and closing properly, then it was noticed that part of the jaw had broken off inside the patient.The piece was so small that had to be flushed out of the joint but it is unknown if it was completely removed.Surgery was completed with a back-up device instead.There was a surgical delay of less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 b5 and h6: event description and codes updated.
Event or Problem Description
It was reported that, during an arthroscopic procedure, the novostitch jaw was not opening and closing properly, then it was noticed that part of the jaw had broken off inside the patient.The piece was so small that had to be flushed out of the joint, post operative x-rays were clear.Surgery was completed with a back-up device instead.There was a surgical delay of less than 30 minutes, and no further complications were reported.

• 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: 21694823
• Report Number: 3009131204-2025-00003
• Device Sequence Number: 9281744
• Product Code: GAT
• UDI-Device Identifier: 00853541006051
• UDI-Public: 853541006051
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2025

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 Expiration Date: 08/02/2026
• Device Catalogue Number: CTX-A004
• Device Lot Number: M240132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 05/20/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/16/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2024
• 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
• Patient Sex: Unknown