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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FIBULA COMP LOCK PLATE 8H STE PLATE, FIXATION

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ZIMMER BIOMET, INC. FIBULA COMP LOCK PLATE 8H STE PLATE, FIXATION Back to Search Results
Catalog Number 856204008
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 02/25/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign ¿ (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01335, 0001825034-2019-01334, 0001825034-2019-01333, 0001825034-2019-01332, 0001825034-2019-01331, 0001825034-2019-01330, 0001825034-2019-01329, 0001825034-2019-01328, 0001825034-2019-01327, 0001825034-2019-01326, 0001825034-2019-01324, 0001825034-2019-01323, 0001825034-2019-01322, 0001825034-2019-01321, 0001825034-2019-01320, 0001825034-2019-01319, 0001825034-2019-01318, 0001825034-2019-01316. 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 mdr will be submitted. Product not returned.
 
Event Description
It was reported that incoming inspection member found crease and channel on the sterile package. There was no patient involvement.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Review of the returned products confirms that there are creases in the seal where the pouch was folded to be inserted into the outer carton. The creases in the seals are cosmetic and did not affect sterility or product function. The returned products are found to be within specifications. 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.
 
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Brand NameFIBULA COMP LOCK PLATE 8H STE
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8441182
MDR Text Key139573464
Report Number0001825034-2019-01335
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number856204008
Device Lot Number043050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/24/2019
Is This a Reprocessed and Reused Single-Use Device? No

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