MAUDE Adverse Event Report: CETERIX ORTHOPAEDICS, INC NOVOSTITCH CARTRIDGE 2-0; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	CTX-R001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the novostitch cartridge broke off in the patient, leaving a metal piece inside of his anatomy.Incident occurred after the procedure, when a scan was performed on the patient, showing the metal piece.The procedure was completed using the same device and there was no delay.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: visual inspection and functional testing could not be performed because the device, used in treatment, was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.The risk management documentation was reviewed and found to contain this failure mode within the risk file, no updates are required.Clinical/medical evaluation was completed and concluded that based on the limited information provided, the root cause could not be confirmed.However, excessive force on the instrument was likely and is a known risk addressed in the instruction for use.This could not be ruled out as a potential contributing factor.The retained metal piece is not biocompatible.Additionally, the scan confirmed the retained metal piece, however, the location was not provided.Therefore, we cannot rule out the possible of pain, mri restriction or migration/ micro-motion of the retained metal piece.The impact on the patient beyond the procedure and retained metal piece cannot be determined.Since the procedure completed immediately with the same device; no further clinical/medical, assessment is warranted at this time.Should additional medical information be provided, this complaint will be re-assessed.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• Brand Name: NOVOSTITCH CARTRIDGE 2-0
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): CETERIX ORTHOPAEDICS, INC; 6500 kaiser dr ste 120; fremont CA 94555
• MDR Report Key: 10261825
• Report Number: 3009131204-2020-00016
• Device Sequence Number: 11725881
• Product Code: GAT
• UDI-Device Identifier: 00853541006105
• UDI-Public: 00853541006105
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K063778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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 Model Number: CTX-R001
• Device Catalogue Number: CTX-R001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/11/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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