MAUDE Adverse Event Report: ZIMMER GMBH FLEXIBLE SHAFT, TRI-SHANK; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a procedure, the doctor was drilling through the cup into the acetabulum and the drill sheared into two pieces.There was no impact on the patient or the surgery.No delay was caused.Both pieces were removed within a matter of seconds and surgery continued as usual.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and the part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.As the device was not returned and no pictures were provided, the reported event could not be confirmed.However, for fractured instruments ie was previously addressed.With the available information, 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h6, h11.Device shows wear to the shank, shaft, flexible shaft, and distal tip from previous uses.High magnification of the flexible shaft on both areas near the fracture exhibit dark lines consistent with cracks.No other damage was noted.Device had an approximate field age of 9 years from event date.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and 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.The instrument was manufactured in 2015 and likely fractured due to wear and tear from repeated use over time in the field; therefore the fracture is most likely due to the high torque forces during nearly 10 years of use and does not suggest a manufacturing issue.However, with the available information, a definitive root cause cannot be established.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
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: FLEXIBLE SHAFT, TRI-SHANK
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20788143
• Report Number: 0009613350-2024-00548
• Device Sequence Number: 7980757
• Product Code: HWE
• UDI-Device Identifier: 00889024277014
• UDI-Public: (01)00889024277014(11)150914(10)15173563
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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 Model Number: N/A
• Device Catalogue Number: 00879000705
• Device Lot Number: 15173563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 05/19/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/20/2024; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2015
• 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