MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW; ROD, FIXATION, INTRAMEDULLARY

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/02/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products:¿ cephalomedullary femoral nail ccd 130, right, 10 mm, l.18 cm item#47249318210 lot#2713962 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head item#47248403250 lot#62598291.Report source: japan.No product was returned or pictures provided: product evaluation could not be performed.A review of the manufacturing records identified no deviations or anomalies during manufacturing.A device used for treatment.Medical records were not provided.With the available information, 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.
Event or Problem Description
It was reported that the patient underwent revision surgery due to pain at the surgical site.The femoral nail and lag screw were revised.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• 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: 16192451
• Report Number: 0009613350-2023-00002
• Device Sequence Number: 4385843
• Product Code: HSB
• UDI-Device Identifier: 00889024298460
• UDI-Public: (01)00889024298460(17)180630(10)2714477
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2023

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: 06/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-105-10
• Device Lot Number: 2714477
• 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: 03/29/2016
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2013
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male