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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10.5 X 85 LAG SCR TRAUMA PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10.5 X 85 LAG SCR TRAUMA PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Activation, Positioning or SeparationProblem (2906); Activation Problem (4042)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  Injury  
Event Description
It was reported that operation was performed with cm fortis nail system. After 2 months from the initial, surgeon confirmed x-rays and he found the lag screw was sliding to outer side. The surgeon keep an eye on the patient condition as well as no revision will be planned so far. No delay. Patient involvement. No further outcome.
 
Manufacturer Narrative
Concomitant medical products: catalog#: 47-2484-027-50; lot#: 64997539; catalog#: 47-2484-027-50; lot#: 65138798; catalog#: 47-2500-002-00; lot#: 3056982; catalog#: 00-2490-101-22; lot#: unknown; catalog#: 00-2490-101-24; lot#: unknown. This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states. The manufacturer did not receive x-rays, or other source documents for review. 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: 0009613350-2022-00119.
 
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Brand NameZ NAIL CMF 10.5 X 85 LAG SCR
Type of DeviceTRAUMA PROSTHESIS
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 Key13658395
MDR Text Key286496813
Report Number0009613350-2022-00118
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2499-085-10
Device Lot Number3072828
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/03/2022 Patient Sequence Number: 1
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