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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PIN INSTRUMENT, KNEE

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ZIMMER BIOMET, INC. UNKNOWN PIN INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05603 and 0001822565-2019-05330. 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 that during a knee procedure, a drill pin was cross-threaded in a cut guide and became stuck. It could not be removed from the cutting block. No adverse events have been reported as a result of the malfunction.
 
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Brand NameUNKNOWN PIN
Type of DeviceINSTRUMENT, KNEE
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 Key9481273
MDR Text Key189989425
Report Number0001822565-2019-05330
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/24/2021
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
Removal/Correction NumberN/A

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