MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD OSTEOTOME 3714338 NEIVERT 4MM SGL GUARD; PFM11

Catalog Number	3714338
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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 rhinoplasty, the tip/end of the chisel/neivert osteotome, 4mm single guarded (b)(6) broke off inside the bone of the patient.It was reported that there was no harm to the patient.It is unknown whether the part was removed or whether a surgical delay occurred.Additional information has been requested.
Additional Manufacturer Narrative
The osteotome neivert 4mm sgl guard (3714338) was returned for evaluation.Failure analysis: the returned 3714338 osteotome was in used condition with the blade chipped.Root cause analysis: the reported complaint was confirmed.Damage to the tip may be the result of rough handling or environmental damage.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: OSTEOTOME 3714338 NEIVERT 4MM SGL GUARD
• Common Device Name: PFM11
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20742019
• Report Number: 3003249645-2024-00056
• Device Sequence Number: 18233165
• Product Code: HWM
• UDI-Device Identifier: 10381780080053
• UDI-Public: 10381780080053
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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 Catalogue Number: 3714338
• Device Lot Number: BN2404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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