MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-BITE CRILE-WOOD NH 6; CARDIOVASCULAR NEEDLE HOLDERS

Catalog Number	121130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full name of the reporting facility is (b)(6) center for facial plastic surgery.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the needle driver/carb-bite crile-wood needleholder 6 (121130) broke during a facial procedure.The tip broke off completely and fell into the surgical site.Staff retrieved the broken end with forceps and flushed the site.It was reported that the delay was not significant, less than 30 minutes; just long enough to open a back-up instrument.Staff was able to complete the procedure.No patient injury occurred.The customer reported that the instrument was not being weighted or used in any rough procedures and have been in use for less than 2 years.
Additional Manufacturer Narrative
The carb-bite crile-wood nh 6 (121130) was not returned for evaluation after three good faith effort (gfe) attempts were made.Lot number has been provided; device history record (dhr) was reviewed and no anomalies related to the reported issue were identified.The root cause of the reported issue could not be determined.However, a probable root cause is that the breaking may have resulted from rough handling or exposure to non neutral ph solution/cleaners, leading to corrosion.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CARB-BITE CRILE-WOOD NH 6
• Common Device Name: CARDIOVASCULAR NEEDLE HOLDERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20112562
• Report Number: 3014334038-2024-00182
• Device Sequence Number: 7349833
• Product Code: MDM
• UDI-Device Identifier: 10381780377115
• UDI-Public: 10381780377115
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Catalogue Number: 121130
• Device Lot Number: AB2303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown