MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-BITE HEANEY NH 8-1/4; N/A

Model Number	121210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1/full reporting facility name: (b)(6).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 was reported via medwatch/uf/importer report # (b)(4)."narrative from staff: during surgery the surgeon noticed that a piece of the needle driver had broken off into patient's vagina while suturing the vaginal cuff during a total laparoscopic hysterectomy.The piece was retrieved, and the instrument and broken piece was immediately taken off the field.Original intended procedure? : total laparoscopic hysterectomy, bilateral salpingectomy, cystoscopy preexisting characteristics that may have contributed to the event: morbidly obese; surgery" it was subsequently reported that all broken parts of the carb-bite heaney needleholder (121210) were recovered.It was reported that an x-ray was not necessary as staff was able to retrieve all pieces.Following the event, the broken device was removed from the sterile field and provided to risk management.The procedure was completed as normal.No patient harm or surgical delay occurred as a result.
Additional Manufacturer Narrative
The carb-bite heaney nh 8-1/4 (121210 ) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; device history record (dhr) was reviewed and no abnormalities related to the reported issue were identified.A definitive root cause could not be determined.The issue of breakage may be the result of rough handling/environmental damage or wear over four years of use.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 or Problem Description
N/a.

• Brand Name: CARB-BITE HEANEY NH 8-1/4
• 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: 16820968
• Report Number: 3014334038-2023-00054
• Device Sequence Number: 7045515
• Product Code: FHQ
• UDI-Device Identifier: 10381780377474
• UDI-Public: 10381780377474
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2023

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: 121210
• Device Catalogue Number: 121210
• Device Lot Number: AA1803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/08/2023
• Date Device Manufactured: 03/01/2018
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 106 KG