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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.7 MM SQUARE DRIVER; TRAUMA, INSTRUMENT
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ZIMMER BIOMET, INC. 1.7 MM SQUARE DRIVER; TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 231200101
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/25/2018
Event Type  Injury  
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.Product not returned.
 
Event Description
It was reported that the driver fractured and the fractured piece was in the wound and unable to be retrieved.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.The tip of the driver is fractured.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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 further event information available at the time of this report.
 
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Brand Name
1.7 MM SQUARE DRIVER
Type of Device
TRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8001746
MDR Text Key124887858
Report Number0001825034-2018-09918
Device Sequence Number1
Product Code HWR
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 03/22/2019
1 Device was Involved in the Event
1 Patient 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 Number231200101
Device Lot NumberCA5DE24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/01/2018
Initial Date FDA Received10/24/2018
Supplement Dates Manufacturer Received03/20/2019
Supplement Dates FDA Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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