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

Model Number 121135

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2022

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 received via medwatch uf/importer report# (b)(4): "instrument was being used on the field in patient's right leg.Piece of tip was found in leg while using c-arm during procedure.Piece removed from patient and placed in specimen cup with lid.Instrument and specimen cup immediately removed from sterile field and given to circulator.X-ray to confirm no retained objects obtained." original intended procedure: insertion intramedullary nail femur.It was subsequently reported that there was no consequence to patient as a result to product problem and no procedural delay occurred.

Manufacturer Narrative

The carb-bite mayo-hegar nh 6 (121-135) was not returned for evaluation; therefore, an evaluation of the device could not be performed.A lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.A definitive root cause of the reported issue could not be determined.However, the issue of the product breaking may be the result of wear or environmental damage over time.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 MAYO-HEGAR NH 6
• 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: 15611971
• MDR Text Key: 306997225
• Report Number: 3014334038-2022-00229
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10381780377160
• UDI-Public: 10381780377160
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121135
• Device Catalogue Number: 121-135
• Device Lot Number: 100084-1502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2022
• Date Device Manufactured: 02/01/2015
• 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 Age: 22 YR
• Patient Sex: Male