MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-BITE MAYO-HEGAR NH 8; N/A

Model Number	121145
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
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
A facility reported that during the final stages of the case for posterior colpoperineorrhaphy while the surgeon was suturing, the tip of the carb-bite mayo-hegar nh 8 (121145) insert broke off inside the patient.All parts were recovered.The intra-operative staff was able to obtain another needle driver to complete the case.No patient injury or surgical delay occurred.The following statement was subsequently reported via medwatch (b)(4): "while dr.Was suturing, a fragment of metal was noticed on patient's skin.Fragment was inspected and determined to be from needle drivers.The gripping surface of the needle holder jaws was fractured.Supervisor was contacted immediately and came to or.The fragment and needle driver were inspected.It was determined that the fracture was a "clean break," and there were no missing pieces.The surgical team discussed and agreed that there was no retained metal at surgical site, and no x-ray was needed, per dr.".
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no anomalies related to the reported failure were identified.One carb-bite mayo-hegar needleholder (121145) was returned to the manufacturer; however, the product was scrapped prior to evaluation.It was determined, that the issue of the grip breaking off may be the result of rough handling or environmental damage.

• Brand Name: CARB-BITE MAYO-HEGAR NH 8
• Common Device Name: N/A
• 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: 16820970
• Report Number: 3014334038-2023-00053
• Device Sequence Number: 7045517
• Product Code: MDM
• UDI-Device Identifier: 10381780377207
• UDI-Public: 10381780377207
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: 121145
• Device Catalogue Number: 121145
• Device Lot Number: AB2210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/23/2023
• Date Device Manufactured: 10/01/2022
• 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: 39 YR
• Patient Sex: Female