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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP REV GLEN BSPLT REAMER

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ZIMMER BIOMET, INC. COMP REV GLEN BSPLT REAMER Back to Search Results
Model Number N/A
Device Problem Off-Label Use (1494)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr's were filed in association with this reporting: 0001825034 - 2019 - 05468. Report source: (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up/final report will be submitted. The physician still uses the device.

 
Event Description

It was reported the surgeon has inadvertently chipped off chunks of the patient glenoid while reaming due to the inability to clearly visualize the glenoid. The surgeon admittedly uses the reamer off-label. No further information is available at the time of this reporting.

 
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Brand NameCOMP REV GLEN BSPLT REAMER
Type of DeviceREAMER
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9416246
MDR Text Key169238798
Report Number0001825034-2019-05457
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number405806
Device LOT Number405807
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 12/05/2019 Patient Sequence Number: 1
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