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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMING BLADE REAMER

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ZIMMER BIOMET, INC. PATELLA REAMING BLADE REAMER Back to Search Results
Model Number N/A
Device Problem Difficult to Open or Remove Packaging Material
Event Date 08/14/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. 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. Product awaiting return.

 
Event Description

It was reported that the inner peel wrap was stuck to the outer peel causing the inner peel to come away from the packaging in an incomplete manner. No adverse events have been reported as a result of the malfunction.

 
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Brand NamePATELLA REAMING BLADE
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 Key6860643
Report Number0001822565-2017-06370
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00597909529
Device LOT Number63654267
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/26/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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