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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS GLEN BASE EXTRACTOR; EXTREMITIES, INSTRUMENT

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ZIMMER BIOMET, INC. COMP RVS GLEN BASE EXTRACTOR; EXTREMITIES, INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the instrument fractured.No further information has been made available at the time of this reporting.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that some of the prongs have fractured and some of the prongs have bent.Device history record was reviewed and no discrepancies were found.The root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
COMP RVS GLEN BASE EXTRACTOR
Type of Device
EXTREMITIES, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9397082
MDR Text Key197792215
Report Number0001825034-2019-05123
Device Sequence Number1
Product Code HWB
UDI-Device Identifier00880304469839
UDI-Public(01)00880304469839
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number405904
Device Lot Number618680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/06/2019
Initial Date FDA Received12/02/2019
Supplement Dates Manufacturer Received03/27/2020
Supplement Dates FDA Received04/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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