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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; EXTREMITIES, INSTRUMENT
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ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; EXTREMITIES, INSTRUMENT Back to Search Results
Catalog Number 110029132
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2024
Event Type  Injury  
Event Description
It was reported that the instrument fractured during the procedure.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
 
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 report will be submitted.
 
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Brand Name
COMPR METAL IMPACTOR
Type of Device
EXTREMITIES, INSTRUMENT
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 Key19183312
MDR Text Key341060908
Report Number0001825034-2024-01070
Device Sequence Number1
Product Code KWS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193373
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number110029132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/25/2024
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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