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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH ORTHOPEDIC STEREOTAXIC INSTRUMENT

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ZIMMER BIOMET, INC. HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the pin became stuck in a cut block during a total knee arthroplasty. No patient or procedure impact reported. No additional information is available.
 
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Brand NameHEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13635307
MDR Text Key287388447
Report Number0001822565-2022-00622
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00590102000
Device Lot Number65245578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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