MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-BITE CRILE-WOOD NH 8; CARDIOVASCULAR NEEDLE HOLDERS

Model Number	121132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The following information was reported via uf/importer report# (b)(4), received on 14-july-2022: while surgeon was working, needle driver broke in the wound.All pieces found and visualized.X-ray called and 2 views taken and there was no foreign body in wound.Original intended procedure: open reduction internal fixation right distal radius and scaphoid fracture (right) no patient injury, death or surgical delay was reported.Additional information has been requested.
Additional Manufacturer Narrative
The carb-bite crile-wood needle hoodler (121132) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; thus, device history record (dhr) was reviewed, and no anomalies related to the reported issue were identified.A definitive root cause of the reported issue could not be determined.The issue of breaking may be the result of rough handling or environmental damage.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.
Event or Problem Description
N/a.

• Brand Name: CARB-BITE CRILE-WOOD NH 8
• Common Device Name: CARDIOVASCULAR NEEDLE HOLDERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15175503
• Report Number: 3014334038-2022-00175
• Device Sequence Number: 12342774
• Product Code: DWS
• UDI-Device Identifier: 10381780377139
• UDI-Public: 10381780377139
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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 Model Number: 121132
• Device Catalogue Number: 121132
• Device Lot Number: 100084-1703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/08/2022
• Date Device Manufactured: 03/01/2017
• 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: Male