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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 110 LAG SCR TRAUMA PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10.5 X 110 LAG SCR TRAUMA PROSTHESIS Back to Search Results
Catalog Number 47-2499-110-10
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states. The device will not be returned for analysis because it remains implanted; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Zimmer's reference: (b)(4). Concomitant devices: z nail cmf 11. 5mmx17. 5cm 125r; catalog: 47-2498-180-11; lot: 3056778. Multiple mdr reports were filed for this event: 0009613350-2022-00247.
 
Event Description
It was reported that 5 months after the initial implantation, surgeon confirmed through x-rays that the lag screw was sliding to the outer side. Patient is being monitored. No revision planned so far no consequences or impact to patient. Attempts have been made and no further information has been provided yet.
 
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Brand NameZ NAIL CMF 10.5 X 110 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 Key14160761
MDR Text Key289698311
Report Number0009613350-2022-00248
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47-2499-110-10
Device Lot Number3068976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2021
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: 04/20/2022 Patient Sequence Number: 1
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