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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL STANDARD 2.7 MM DIAMETER; TRAUMA, INSTRUMENT
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ZIMMER BIOMET, INC. DRILL STANDARD 2.7 MM DIAMETER; TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 00236020527
Event Date 06/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that during the procedure, the drill bent and fractured while it was being removed from the patient.The tip of the drill bit was retained by the patient.
 
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.Visual examination of the returned product identified the cutting end of the drill has fractured off and was not returned.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Microhardness was measured and found to be conforming to specification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: plate and screw fixation of the proximal tibia is present.A fractured metallic drill bit fragment is present and appears to lie within the proximal tibia.No contributing factors are noted based on this single image.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 2.7 MM DIAMETER
Type of Device
TRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10251249
MDR Text Key199443914
Report Number0001822565-2020-02503
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 09/04/2020
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00236020527
Device Lot Number64391102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/20/2020
Initial Date FDA Received07/09/2020
Supplement Dates Manufacturer Received09/03/2020
Supplement Dates FDA Received09/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
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