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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BICORT DEPTH GAUGE 1.3MM/1.5MM
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ZIMMER BIOMET, INC. BICORT DEPTH GAUGE 1.3MM/1.5MM Back to Search Results
Catalog Number 231220124
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Event Description
It was reported that the depth gauge is broken due to wear and tear.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).G2: south africa.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.
 
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Brand Name
BICORT DEPTH GAUGE 1.3MM/1.5MM
Type of Device
DEPTH GAUGE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key19071309
MDR Text Key340570647
Report Number0001825034-2024-00954
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number231220124
Device Lot NumberSC17D004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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