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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: . FIB ANATOMIC LOCK LEFT 4H STE PLATE, FIXATION

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. FIB ANATOMIC LOCK LEFT 4H STE PLATE, FIXATION Back to Search Results
Catalog Number 856206004
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up report will be submitted. Product not returned.
 
Event Description
It was reported an alps fibula anatomic plate was opened during surgery and the consultant wanted to contour it. While contouring the distal tab, it broke in the surgeons possession. There was no impact to patient safety but did result in a small delay in surgery.
 
Manufacturer Narrative
Device history record was reviewed and no discrepancies were found. Per the surgical technique: bending the distal tab beyond 20 degrees may result in breakage. Continuous bending will also fatigue the tab and cause it to break. From follow up information it is unknown if the plate was bent beyond 20 degrees or not. Therefore, a definitive root cause cannot be determined. 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
No further event information available at the time of this report.
 
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Brand NameFIB ANATOMIC LOCK LEFT 4H STE
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
.
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 Key10374122
MDR Text Key201913516
Report Number0001825034-2020-03088
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K111663
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 01/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number856206004
Device Lot Number890710
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 Received01/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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