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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL BIT 2.2MM NS; TRAUMA, INTSTRUMENT
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ZIMMER BIOMET, INC. DRILL BIT 2.2MM NS; TRAUMA, INTSTRUMENT Back to Search Results
Catalog Number 231200200
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that the instrument fractured during the procedure.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h4, h6, h10.Device history record 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.Product not returned.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
DRILL BIT 2.2MM NS
Type of Device
TRAUMA, INTSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10340636
MDR Text Key200870527
Report Number0001825034-2020-02985
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 company representative,foreig
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number231200200
Device Lot Number329570
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight80
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