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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES MANSFIELD CARB-BITE CRILE-WOOD NH 8; CARDIOVASCULAR NEEDLE HOLDERS Back to Search Results
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.
 
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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 Key15175503
MDR Text Key301717350
Report Number3014334038-2022-00175
Device Sequence Number1
Product Code DWS
UDI-Device Identifier10381780377139
UDI-Public10381780377139
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number121132
Device Catalogue Number121132
Device Lot Number100084-1703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/14/2022
Initial Date FDA Received08/05/2022
Supplement Dates Manufacturer Received08/30/2022
Supplement Dates FDA Received09/08/2022
Date Device Manufactured03/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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