MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC+; BIT, DRILL

Catalog Number	31-323230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H6: proposed component code: mechanical (g04) - drill the product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the drill bit broke during surgery and another drill was used to complete the procedure.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6.The following sections were corrected: h5.Visual examination of the returned product identified drill bit is confirmed fractured within the cutting flute region.The drill bit appears to be slightly bent with multiple small fractures near the fractured surface on the flutes.Small nicks and gouges are present near the fracture on the flutes.No other damage was noted during visual evaluation.Device has an approximate field age of 1 month.The fractured device was further reviewed and it was determined that the fracture surface river lines and hinge artifacts in opposite directions suggests a reverse bending overload mode of failure.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.The root cause is attributed to user error, as the surgeon has mentioned it was an operator error.As per ifu, it states "surgical instruments are subject to wear with normal usage.Instruments with cutting functions or points may become dull with normal use and no longer perform as intended.Inspect prior to use to verify the cutting ability and sharpness of edges., instruments that have experienced extensive use or excessive force are susceptible to fracture." based on the returned product review, the complaint is confirmed.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
No further information is available at the time of this report.

• Brand Name: RINGLOC+
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21696321
• Report Number: 0001825034-2025-00839
• Device Sequence Number: 9059151
• Product Code: HTW
• UDI-Device Identifier: 00887868478703
• UDI-Public: (01)00887868478703(17)350213(10)66930839
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 31-323230
• Device Lot Number: 66930839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male