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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN PIN PIN, FIXATION

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BIOMET ORTHOPEDICS UNKNOWN PIN PIN, FIXATION Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Date 11/15/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). No devices or photos of the devices were received; therefore, the condition of the components is unknown. Additionally, visual and dimensional evaluations could not be performed. The product number and the lot number were not provided; therefore, the manufacturing date, the device history records and the field age of the device could not be determined. There is insufficient information to perform a complaint history search. A definitive root cause could not be determined, as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event please see associated reports:0001825034-2017-02504, 0001825034-2017-02505, 0001825034-2017-02506, 0001825034-2017-02507, 0001825034-2017-02508.

 
Event Description

One patient identified in a journal article reportedly experienced complications including a fall, wound dehiscence, and infection. Attempts to obtain additional information have been made; however, none has been provided and patient outcome is unknown.

 
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Brand NameUNKNOWN PIN
Type of DevicePIN, FIXATION
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6487374
Report Number0001825034-2017-02509
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 04/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL 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 Received03/13/2017
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: 04/12/2017 Patient Sequence Number: 1
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