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	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during surgery, the upper jaw of the novostitch that holds the wire on the device broke before firing the implants, which leaded to a malfunction on the upper jaw.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: one device, used in treatment, was returned for evaluation.There was relationship found between the returned device and the reported incident.Upon investigation, it was determined that the upper jaw hinge had broken.If the hinge is broken, the orange trigger can no longer control the upper jaw and the surgeon will have incomplete stitch.All parts of the device remained attached to the device, no fragments were noted missing.The upper jaw hinge can break when excessive force is applied during use, if the portal placement is low, or jamming the device in and out of the knee or into the structures in knee.The probable root cause for the upper jaw hinge to break could be due to torqueing the device excessively and placing too much force on the hinge and upper jaw.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.A review of the device history records for the reported preloaded suture passer performed there are no indications to suggest that the device/product did not meet specifications upon release into distribution.Per email communication there were no loose broken pieces, the wire broke but it did not detach.The procedure was completed using a backup device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.A review of the complaint history for lot number found no similar events prior to the complaint event.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.The instruction for use discusses all surgical hazards in warning section.In instructions for use warning notes, ¿do not force the device into tight joint spaces.Excessive pushing, twisting or levering may cause breakage.¿ there are no indications to suggest that the device/product did not meet specifications upon release into distribution.Internal complaint reference: case-(b)(4).

• 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
• MDR Report Key: 11283710
• Report Number: 3009131204-2021-00005
• Device Sequence Number: 3440687
• Product Code: GAT
• UDI-Device Identifier: 00853541006051
• UDI-Public: 00853541006051
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: 12/01/2021
• Device Model Number: CTX-A004
• Device Catalogue Number: CTX-A004
• Device Lot Number: M190344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention