MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER MIS ADJUSTABLE INTRAMEDULLARY FEMORAL GUIDE; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: spain.The complainant 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.H3 other text : investigation incomplete.
Event or Problem Description
It was reported that during knee arthroplasty the adjustable intramedullary femoral guide became hooked in the patient's femur and could not be extracted.Surgery was delayed one hour to remove the guide from the femur.Cerclage cables were used to stabilize the damage sustained to the patient's femur.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that during knee arthroplasty the adjustable intramedullary femoral guide became hooked in the patient's femur and could not be extracted.The surgeon attempted to use other instrumentation to remove the guide, however, was unsuccessful, and resorted to cutting into the patient's bone to remove the guide.Surgery was delayed one hour to remove the guide from the femur.Cerclage cables were used to stabilize the damage sustained to the patient's femur.The patient did not require any additional care post-operatively.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of pictures provided identified that the femoral guide showed signs of use with no gross visual defects.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h4; h6.Visual examination of the returned product identified signs of use (gouges) and confirming complaint the guide posts are fractured.Not all pieces were returned.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Analysis determined the optical images of the device fracture surface exhibited excessively smeared surface for the most part.However, a portion of non-smeared surface on the device showed indications of river line artifacts suggesting that the device was suspected to have fractured due to bending overload.Root cause remains unchanged.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER MIS ADJUSTABLE INTRAMEDULLARY FEMORAL GUIDE
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; .; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18932404
• Report Number: 0001822565-2024-00932
• Device Sequence Number: 15789443
• Product Code: FZX
• UDI-Device Identifier: 00889024212923
• UDI-Public: (01)00889024212923(10)64298338
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596704200
• Device Lot Number: 64298338
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 03/22/2024; 08/22/2024; 06/27/2025
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 03/22/2024; 08/28/2024; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown