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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA UNKNOWN TRAUMA FIXATION SCREW SCREW, FIXATION

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BIOMET TRAUMA UNKNOWN TRAUMA FIXATION SCREW SCREW, FIXATION Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 09/10/2012
Event Type  Injury  
Manufacturer Narrative

(b)(4). It has been indicated by the customer that the product will not be returned to zimmer biomet for investigation as the location of the product currently remains unknown. Concomitant medical products - 2. 2mm x 28 guide wire catalog #: 8092-22-028 lot #: e2pag7, endcap impinging catalog #: 8007-00-000 lot #: dldbcf, versanail tibiotalocalcaneal ankle fusion nail catalog #: 800710025 lot #: dlncl1. Multiple mdr reports were filed for this patient; please see associated reports: 0001825034-2014-00546, 0001825034-2017-02592, 0001825034-2018-03394. Inadequate information received.

 
Event Description

It is reported that the patient experienced pain and malunion, first noted approximately two months following removal of a migrated distal screw. Subsequently, patient underwent an ankle fusion nail revision due to pain and delayed union approximately 1. 5 years post-implantation. All components were removed.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The product was not evaluated, but the reported event was confirmed through review of operative records. A device history record review was not performed as the lot number associated with the reported event is unknown. Operative records provided confirm that the patient underwent an ankle procedure to remove the intramedullary rod and locking screws due to painful hardware. The procedure was completed successfully with no complications. Based on the limited information provided, 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.

 
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Brand NameUNKNOWN TRAUMA FIXATION SCREW
Type of DeviceSCREW, FIXATION
Manufacturer (Section D)
BIOMET TRAUMA
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 Key7517895
Report Number0001825034-2018-03393
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 05/16/2018 Patient Sequence Number: 1
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