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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETRO FEMUR MOD TARG GUIDE INSTRUMENT, TRAUMA

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ZIMMER BIOMET, INC. RETRO FEMUR MOD TARG GUIDE INSTRUMENT, TRAUMA Back to Search Results
Catalog Number 00249000430
Device Problem Positioning Failure (1158)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02562, 0001822565-2020-02561, 0001822565-2020-02876. Concomitant medical devices: item# 00249000424; lot# 61793873; item# 00249000432; lot# 63206145; item# 00249000431; lot# 63199333. 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. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported approximately three (3) months ago during an initial surgery, the retrograde nail jig attachment would not line up to the proximal holes. There was a 35 minute delay. Attempts have been made and no further information has been provided.
 
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Brand NameRETRO FEMUR MOD TARG GUIDE
Type of DeviceINSTRUMENT, TRAUMA
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 Key10392019
MDR Text Key202422678
Report Number0001822565-2020-02875
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00249000430
Device Lot Number63210804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberNI

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