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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET END CAP 12X5MM E 12X5MM ROD, FIXATION

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ZIMMER BIOMET, INC. OFFSET END CAP 12X5MM E 12X5MM ROD, FIXATION Back to Search Results
Catalog Number 14-444181
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Udi#: (b)(4). Concomitant medical devices: 14-444232, fem nail retro 10. 5mm x 320mm mm x 32cm 662480; 14-405075, ti-dble lead cort 5. 0x75mm scr ia5. 0x75mm 907650. Report source: 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 mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01412, 0001825034 - 2020 - 01413.
 
Event Description
It was reported that initial phoenix retro nail surgery was performed. Two weeks post-implantation the screw started to migrate from its original position and the endcap came off. A revision procedure was performed to explant the endcap and re-insert the screw. No additional patient consequences were reported.
 
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Brand NameOFFSET END CAP 12X5MM E 12X5MM
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 Key9962158
MDR Text Key191532969
Report Number0001825034-2020-01411
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number14-444181
Device Lot Number873980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2019
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: 04/15/2020 Patient Sequence Number: 1
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