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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL STANDARD; TRAUMA, INSTRUMENT
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ZIMMER BIOMET, INC. DRILL STANDARD; TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 00236020527
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(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 mdr will be submitted.Product not returned.
 
Event Description
It was reported that during the procedure, the drill fractured.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.
 
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Brand Name
DRILL STANDARD
Type of Device
TRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8564415
MDR Text Key143685874
Report Number0001822565-2019-01771
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 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00236020527
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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