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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ANKLE FIX DRILL-GUIDE 3.2 SYS 4RED 65MM NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0

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ZIMMER GMBH ANKLE FIX DRILL-GUIDE 3.2 SYS 4RED 65MM NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0 Back to Search Results
Model Number N/A
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
The manufacturer did not receive devices for review. X-rays or other source documents were not provided for review. As no lot numbers were provided for the devices, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. Additional information has been requested and is currently not available. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. (b)(4).
 
Event Description
It was reported that during an ankle fusion surgery, while using the compression device, the two drill guides used along with it buckled at the point where they screw into the plate, the threaded section one was snapped. Following this the surgeons then struggled to get the locking screws to sit flush within the plate.
 
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Brand NameANKLE FIX DRILL-GUIDE 3.2 SYS 4RED 65MM
Type of DeviceNORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER 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 Key7608845
MDR Text Key111443452
Report Number0009613350-2018-00625
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK123347
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 11/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number503004047
Device Lot Number028A15
Other Device ID Number00889024111547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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