MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CARB-BITE DEBAKEY NH 8; CARDIOVASCULAR NEEDLE HOLDERS

Model Number	121186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
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
It was reported that during a heart operation, the surgeon noticed that a piece of the debakey carb-bite needle holder (121186) was missing.Before the end of the operation, an x-ray test was done.The missing piece was not found in the patient¿s body.Medical staff did not know at which stage the device broke, but suspected it was at the beginning of the operation.The event did not lead to patient injury; however, a two-hour increase in surgery time was reported.
Additional Manufacturer Narrative
The suspected carb-bite debakey needle holder (121186) was returned for evaluation: the needle holder was received in used condition with part of the tip's carbide grip broken off.Per the customer, this product had been purchased in 2011.The issue of grip breaking off may be the result of wear or environmental damage.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Additional Manufacturer Narrative
The suspected carb-bite debakey needle holder (121186) was returned for evaluation: the needle holder was received in used condition with part of the tip's carbide grip broken off.Per the customer, this product had been purchased in 2011.Inspection by the current supplier for this product identified that it was manufactured by a previous supplier in 2010.The issue of grip breaking off may be the result of wear or environmental damage.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
Event or Problem Description
N/a.

• Brand Name: CARB-BITE DEBAKEY NH 8
• Common Device Name: CARDIOVASCULAR NEEDLE HOLDERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15496596
• Report Number: 3014334038-2022-00207
• Device Sequence Number: 5243220
• Product Code: DWS
• UDI-Device Identifier: 10381780165071
• UDI-Public: 10381780165071
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2023

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: 121186
• Device Catalogue Number: 121186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 11/07/2022; 01/17/2023
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/15/2022; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 77 YR
• Patient Sex: Male