MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: nail snapped at lag screw junction.
Additional Manufacturer Narrative
Concomitant medical product: cmn femoral nail, ccd 125°, right,11.5 mm, 38 cm catalog#: 47-2493-380-11 ; lot#: 2973776.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2022-00054.
Event or Problem Description
Investigation of this incident has been completed.Attempts have been made and no further information has been provided further analysis of the event has determined that according to complaint description, the device here reported is not a main but an associates device.
Additional Manufacturer Narrative
This report is being filed to relay additional information, which was unknown at the time of the previous submitted report.Investigation results are now available.During the investigation it was concluded that the device previously submitted on this medwatch is a concomitant and not a main device of this event.Please remove from your records.This device is reported in 0009613350-2022-00054-1 as a concomitant device.Zimmer's reference: (b)(4).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: ZNN, CMN LAG SCREW, 10.5 MM, 90 MM, INCLUDING SET SCREW
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• 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: 13440250
• Report Number: 0009613350-2022-00056
• Device Sequence Number: 2110103
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: 00889024298439
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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 Expiration Date: 05/08/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 3071946
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2021
• 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
• Patient Sex: Female