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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. RUSH AWL 2.5MM DIAMETER REAMER ELBOW INSTRUMENT

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ZIMMER, INC. RUSH AWL 2.5MM DIAMETER REAMER ELBOW INSTRUMENT Back to Search Results
Catalog Number 31810616700
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 07/28/2016
Event Type  Malfunction  
Manufacturer Narrative

The reamer was returned for evaluation. As returned, the awl is bent and has fractured at the base of the handle. Review of receiving inspection report for the device indicates the devices were manufactured to specifications. Inspection documentation shows all devices that were inspected met specifications. Wear & tear is seen that indicates successful use during a potential field age of approximately 10 years 10 months. Dimensional measurements are conforming to print specifications. The instrument was manufactured on september 22, 2005. This device is used for treatment. Initial product history search conducted on september 28th 2016 revealed no additional complaints against the related part and lot combination. Wear and tear has been determined to be the root cause for the instrument fracture.

 
Event Description

It is reported that the device was found to be fractured during kit inspection.

 
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Brand NameRUSH AWL 2.5MM DIAMETER REAMER
Type of DeviceELBOW INSTRUMENT
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6190321
MDR Text Key63312870
Report Number0001822565-2016-04753
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
PMA/PMN NumberPEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 12/20/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number31810616700
Device LOT Number60351086
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2016
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/22/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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