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

Model Number	121135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2022
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 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.
Additional 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
• 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: 15611971
• Report Number: 3014334038-2022-00229
• Device Sequence Number: 2762451
• Product Code: DWS
• UDI-Device Identifier: 10381780377160
• UDI-Public: 10381780377160
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 121135
• Device Catalogue Number: 121-135
• Device Lot Number: 100084-1502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/04/2022
• Date Device Manufactured: 02/01/2015
• 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 Age: 22 YR
• Patient Sex: Male