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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL - GREEN RIGHT 13 MM DIAMETER 38 CM LENGTH ROD, FIXATION

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ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL - GREEN RIGHT 13 MM DIAMETER 38 CM LENGTH ROD, FIXATION Back to Search Results
Catalog Number 47249238013
Device Problem Failure to Align (2522)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that the implant was incorrectly positioned in the femur. The alignment was not verified prior to attempting to drill the screw holes. The drill became jammed in the implant and fractured. A guide wire was placed in the second screw hole on the proximal end of the nail and it also fractured. The surgeon successfully placed a screw in the third screw hole. The guide wire and drill fragments were left in situ. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameGREATER TROCHANTER FEMORAL NAIL - GREEN RIGHT 13 MM DIAMETER 38 CM LENGTH
Type of DeviceROD, FIXATION
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 Key9929559
MDR Text Key186597059
Report Number0001822565-2020-01258
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K083497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue Number47249238013
Device Lot Number62051907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2020 Patient Sequence Number: 1
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