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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER FEMORAL AWL

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ZIMMER, INC. ZIMMER FEMORAL AWL Back to Search Results
Model Number 2237-61
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 07/01/2021
Event Type  malfunction  
Event Description
As the instrument was being removed, the tip broke off.
 
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Brand NameZIMMER FEMORAL AWL
Type of DeviceAWL
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
MDR Report Key12173309
MDR Text Key261726793
Report Number12173309
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2237-61
Device Catalogue Number00-2237-061-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2021
Event Location Hospital
Date Report to Manufacturer07/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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