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

Model Number 121132

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

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 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.

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 Description

N/a.

• Brand Name: CARB-BITE CRILE-WOOD NH 8
• Type of Device: 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
• MDR Text Key: 301717350
• Report Number: 3014334038-2022-00175
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10381780377139
• UDI-Public: 10381780377139
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/30/2022
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male