MAUDE Adverse Event Report: BIOMET UK LTD. ASI STEEP O/S RASP HANDLE - B; INSTRUMENT, KNEE.

Catalog Number	110029102
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2.Report source: canada.Product was returned and visual examination of the returned device confirmed that the lever to body pin is fractured in half but still retained within the device.The welds on both ends of lever to body pin are broken as well.The fractured pin has an indentation on one end.The device shows signs of use with indentations on the strike plate end and along main body of handle.Scratches and nicks are present along main body of handle along with rasp connection end.The hex screw has a stripped hex.No other damage was noted during visual evaluation.Device has an approximate field age of 2.5 years.The device was sent for further analysis which reported that optical images of the fractured pin showed river lines artifacts throughout suggesting a bending overload mode of failure.The fracture surface also showed an unusual central line artifact that is possibly a result of post fracture damage.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A complaint history was conducted on the lot number now it is known which identified similar complaints for the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Based on the available information, the reported event can be confirmed.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a procedure, the doctor was broaching the femoral canal, but the broach handle wasn¿t working properly, it was loose.No harm to patient.Upon receipt and evaluation of the device, it was found to be fractured.Diligence is completed and no further information on the reported event has been provided.

• Brand Name: ASI STEEP O/S RASP HANDLE - B
• Common Device Name: INSTRUMENT, KNEE.
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22866781
• Report Number: 0009613350-2025-00666
• Device Sequence Number: 15792551
• Product Code: LXH
• UDI-Device Identifier: 05019279998395
• UDI-Public: (01)05019279998395(10)908030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: 110029102
• Device Lot Number: 908030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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