MAUDE Adverse Event Report: ZIMMER GMBH PROXIMAL HUMERUS, LEFT, LONG, ÿ 7X260MM; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial procedure the implant was broken.Due diligence is in progress for this complaint; to date, no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: unknown drill unknown item# and lot #.G2: foreign: spain.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b5, d10, g3; h2; h3; h6 d10: affixus hum calib drill 3.3mm item # 110035650 lot# unknown the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial procedure a drill broke while the nail was being implanted, the nail broke too.It was reported that the event was due to a wrong use of the product and not due to a failure of the products.Due diligence has been completed for this complaint; to date all available additional information has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10, h11.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 that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.An intraoperative fluoroscopy image was provided, showing the implanted nail and two screws.A sharp-tipped object is visible near the proximal end of the nail, most likely the fractured drill bit reported in this event.No issues with the implants are detected based on the image provided.Since this is an intra-op image this can only prove the fracture of the drill bit.Based on the information received, the reported event was most likely due to misuse during the surgery.It has been clarified that the issue did not stem from a product failure or defect but rather from an error in the surgical technique employed.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.

• Brand Name: PROXIMAL HUMERUS, LEFT, LONG, ÿ 7X260MM
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 20213099
• Report Number: 0009613350-2024-00449
• Device Sequence Number: 12563448
• Product Code: HSB
• UDI-Device Identifier: 00889024506046
• UDI-Public: (01)00889024506046(17)340104(10)3181184
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K200814
• 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
• Report Date (Section B): 01/14/2025

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: 47249626107
• Device Lot Number: 3181184
• Was Device Available for Evaluation?: No
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 01/08/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 09/24/2024; 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Patient Sex: Unknown