MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BUZZ NONSTICK: LENGTH: 21.6CM (8.50), TIP SIZE:; N/A

Model Number	NHI10
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
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
This is 2 of 2 reports for the bipolar forceps reportedly used during this event and is linked to mfg report number 3014334038-2022-00170.A facility reported that during an ortho/spine procedure, it was noted that the bipolar forceps/buzz nonstick (nhi15) were no longer conducting at the tips.It was reported that there was a delay of 30 minutes to an hour because the staff had to open replacement instruments.The procedure was completed with replacement instruments.No patient injury occurred.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 the buzz nonstick (nhi10) was returned for evaluation: device history record (dhr): the dhr was reviewed and no abnormalities related to the reported issue were identified.Visual evaluation noted that the returned buzz nonstick forceps were in used condition with the tips tarnished and the insulation worn and discolored due to wear/sterilization issues.Damaged tips and insulation may have interfered with conductivity.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: BUZZ NONSTICK: LENGTH: 21.6CM (8.50), TIP SIZE:
• 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: 15175104
• Report Number: 3014334038-2022-00171
• Device Sequence Number: 5035000
• Product Code: GEI
• UDI-Device Identifier: 10381780149187
• UDI-Public: 10381780149187
• Combination Product (Y/N): N
• PMA/510(K) Number: K051429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: NHI10
• Device Catalogue Number: NHI10
• Device Lot Number: AN2009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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 Sex: Unknown