MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD ELEVATOR 3714040 WOODSON DBL 10/30DEG; PFM11

Catalog Number	3714040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the elevator 3714040 woodson dbl 10/30deg (3714040) broke off in the patient's nose during a closed reduction nasal fracture procedure.The broken piece was retrieved from the nose without any complications related to the broken elevator.Another instrument was used to complete the surgery.No injuries, or death, but an additional five-minute delay was reported.
Additional Manufacturer Narrative
The elevator 3714040 woodson dbl 10/30deg (3714040) was returned for evaluation: the device history record (dhr) was reviewed, and no abnormalities related to the reported issue were observed.Failure analysis: the returned 3714040 elevator is in used condition.On visual inspection, the returned 3714040 elevators had broken off the end tip due to wear or rough handling.The product lot number (cf2106) indicates a manufacture date of 2021 and does not match the lot of the new product sold on the sales order indicated by the customer's lot number ay2412.The customer may have mistaken this older item for a brand-new item.Root cause analysis: the reported complaint was confirmed.The returned 3714040 elevator is in used condition with the end tip broken off due to wear or rough handling.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: ELEVATOR 3714040 WOODSON DBL 10/30DEG
• 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: 22542348
• Report Number: 3014334038-2025-00103
• Device Sequence Number: 15197333
• Product Code: KAD
• UDI-Device Identifier: 10381780078012
• UDI-Public: 10381780078012
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 3714040
• Device Lot Number: CF2106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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