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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CM LAG SCREW REAMER 3.2MM ID ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER BIOMET, INC. CM LAG SCREW REAMER 3.2MM ID ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 00249003244
Device Problem Fracture (1260)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
 
Event Description
The patient had malignancy in the it area of the right hip characterized by incredibly dense bone tumor. The surgeon decided to place a nail to address the disease progression. Because of the hardness of the bone, the surgeon was unable to easily drill through it with the lag screw reamer. The last inch of the instrument fractured in the patient femoral head and was removed without issue. When the surgeon tried to place the lag screw, the tabs fractured due to the dense bone as well. The patient did not retain a foreign device. No further information is available at the time of this reporting.
 
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Brand NameCM LAG SCREW REAMER 3.2MM ID
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key8869187
MDR Text Key153525461
Report Number0001822565-2019-03339
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249003244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/13/2020
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 Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/07/2019 Patient Sequence Number: 1
Treatment
47248511010 CMN LAG SCREW, LOT 2969988
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