MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC +; INSTRUMENT, HIP

Catalog Number	31-424204
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H6: mechanical (g04) - drill.Visual examination of the returned product identified hudson shank has gouges and scratches from use.Flexible shaft is confirmed bent at approximately mid shaft.No other damage was noted.Device has an approximate field age of 1 year 10 months.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.The event description mentions the tech had accidentally hit power release handing power to surgeon prior to using the drill, however it is not known whether this contributed to the flexible shaft becoming broken and holding the bent shape.Based on the returned product, 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
It was reported that while drilling for the screw, the drill got caught and spun inside the cup, which bent the flexible drill.The tech had accidentally hit power release when handing the drill to the surgeon.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.

• Brand Name: RINGLOC +
• Common Device Name: INSTRUMENT, HIP
• 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: 22693365
• Report Number: 0001825034-2025-02348
• Device Sequence Number: 18219275
• Product Code: JDI
• UDI-Device Identifier: 00887868480256
• UDI-Public: (01)00887868480256(11)230509(10)231233
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 31-424204
• Device Lot Number: 231233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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