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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. NEXGEN HEADLESS TROCAR DRILL PIN 3.2MM DIAMETER 75MM LENGTH INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
Event Type  malfunction  
Event Description
It was reported that during a partial knee arthroplasty, the drill pin became jammed in the tibial cut guide. The procedure was completed utilizing another device. No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: medical devices: persona partial knee tibial cut guide 5 degrees catalog #: 42539905195; lot #: 64687543. The 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.
 
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Brand NameNEXGEN HEADLESS TROCAR DRILL PIN 3.2MM DIAMETER 75MM LENGTH
Type of DeviceINSTRUMENT, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14517059
MDR Text Key292964843
Report Number0001822565-2022-01552
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,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00590102000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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