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	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a meniscal repair procedure, the novostitch upper jaw was broken, it could not be manipulated.The tip broke inside the patient, all the pieces were removed.The procedure was completed without a significant delay.There was a change in the surgical technique.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a meniscal repair procedure, the novostitch upper jaw was broken, it could not be manipulated.The tip broke inside the patient, all the pieces were removed.The procedure was completed without a significant delay.There was a change in the surgical technique.No further complications were reported.
Additional Manufacturer Narrative
Additional information provided: d4: expiration date h4: manufacturing date corrections made in the following fields: b5: event description d4: lot number e1: physician information e3: reporter occupation h6: health effect - impact code.
Event or Problem Description
It was reported that during a meniscal repair procedure, the novostitch upper jaw was broken and it could not be manipulated.The tip broke inside the patient, pieces were removed using suction.The procedure was completed with a change in surgical technique with a 30 min delay.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: "the reported device was received for evaluation.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.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.Smith and nephew has not received adequate clinical information to perform a thorough medical investigation nor to determine a definitive root cause of the reported failure.According to the report, the broken piece was retrieved from the patient.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.An analysis of the customer provided images found the linkage to the upper jaw is broken.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, attempted correction of a damaged device, or an inadvertent impact event.No containment or corrective actions are recommended at this time.".
Additional Manufacturer Narrative
H10: additional information on b4.
Event or Problem Description
It was reported that, during a meniscal repair procedure, the novostitch upper jaw was broken, it could not be manipulated.The tip broke inside the patient, all the pieces were removed by suction.The procedure was completed without a significant delay.There was a change in the surgical technique.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: 13390426
• Report Number: 3009131204-2022-00001
• Device Sequence Number: 4252652
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/08/2022

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: 05/26/2023
• Device Model Number: CTX-A004
• Device Catalogue Number: CTX-A004
• Device Lot Number: M210116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2022
• Supplement Date Received by Manufacturer: 01/31/2022; 01/31/2022; 03/07/2022
• Initial Report FDA Received Date: 01/30/2022
• Supplement Report FDA Received Date: 02/02/2022; 02/03/2022; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown