MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD LAMBOTTE OSTEOTOME CVD 1/4; INSTRUMENTS - CUTTING & DISSECTING

Catalog Number	250260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lambotte osteotome cvd 1/4 (250260) was not returned for an evaluation.The product lot number was not provided; therefore, the device history record was not available for review.There has been no return of product for evaluation.No contact or customer information was available on the form.Therefore, a definitive root cause cannot be determined.The issue of breaking may be the result of wear or rough handling.
Event or Problem Description
The following was reported via medwatch/mdr report # mw:5188148: "during a total hip revision, while attempting to take out liner using a 1/4 osteotome, the osteotome broken half." it is unknown whether patient injury or surgical delay occurred; however, it was mentioned that the failure required an intervention, and the specificity of the intervention was not mentioned.No initial reporter details were provided; thus, no request for additional information is possible at this time.

• Brand Name: LAMBOTTE OSTEOTOME CVD 1/4
• Common Device Name: INSTRUMENTS - CUTTING & DISSECTING
• 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: 25460678
• Report Number: 3014334038-2026-00047
• Device Sequence Number: 18728888
• Product Code: GFI
• UDI-Device Identifier: 10381780384083
• UDI-Public: 10381780384083
• 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): 06/10/2026

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: 250260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 74 YR
• Patient Sex: Male
• Patient Race: White