MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 120 MM INCLUDING SET SCREW; HIP INTERNAL FIXATION SYSTEM

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products cmn femoral nail, ccd 130, left, 10 mm, 34 cm, item#: 47249334310, lot#: 3020635.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, item#: 47248403550.Lot#: 65007883.Cephalomedullary nail cap 5 mm height, item#: 47248700205, lot#: 64745428.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, item#: 47248403750, lot#: 64997560.Cable cerclage cable with crimp 1.8 mm dia.635 mm length, item#: 00223200418, lot#: 65046164.Report source- germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00508.
Event or Problem Description
It was reported that a patient underwent a procedure to repair a left, comminuted, subtrochanteric fracture.On an unknown timeframe post-implantation, the connection between the titanium rod of the femur and the screw spindle of the joint head loosened and shifted.The fracture has not healed due to the loosening and constant movements.Additional surgery is pending.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.A definitive root cause cannot be determined.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.H3 other text : currently still implanted.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 120 MM INCLUDING SET SCREW
• Common Device Name: HIP INTERNAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 15526764
• Report Number: 0009613350-2022-00509
• Device Sequence Number: 16812938
• Product Code: HSB
• UDI-Device Identifier: 00889024298491
• UDI-Public: (01)00889024298491(17)250731(10)3042375
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 11/22/2022

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: Lay User/Patient
• Device Expiration Date: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-120-10
• Device Lot Number: 3042375
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male