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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL BIT QUICK-CONNECT 3.5 MM DIAMETER; BIT, DRILL
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ZIMMER BIOMET, INC. DRILL BIT QUICK-CONNECT 3.5 MM DIAMETER; BIT, DRILL Back to Search Results
Catalog Number 00480611035
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).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.
 
Event Description
It was reported that when the product was received at the warehouse the plastic tube did not contain the instrument.There was no patient or surgical involvement.
 
Manufacturer Narrative
A review of the provided photograph shows the product label visible, however, the photo did not identify any indication of the product missing.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 additional event information is available at the time of this report.
 
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Brand Name
DRILL BIT QUICK-CONNECT 3.5 MM DIAMETER
Type of Device
BIT, DRILL
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10815899
MDR Text Key215484158
Report Number0001822565-2020-03792
Device Sequence Number1
Product Code HTW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00480611035
Device Lot Number64707418
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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