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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 125 DEG 11MM X 360MM TRAUMA, IMPLANT

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ZIMMER BIOMET, INC. HFN RH 125 DEG 11MM X 360MM TRAUMA, IMPLANT Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 01/14/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: item# 814550040; lot# m18650a; cortical bone scr 5. 0mm x 40mm; item# 814550040; lot# m15109a; cortical bone scr 5. 0mm x 40mm; item# 814510110; lot# vj1111310b; hfn lag screw 10. 5mm x 110mm; item# 814501095; lot# uk1111295c; hfn a/r screw 95mm. Foreign: event occurred in (b)(6). 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 the patient underwent an initial procedure on an unknown date. Subsequently, the patient was revised due to fracture of the affixus nail. Attempts have been made and additional information on the reported event is unavailable at this time. No additional patient consequences were reported.
 
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Brand NameHFN RH 125 DEG 11MM X 360MM
Type of DeviceTRAUMA, IMPLANT
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 Key11265856
MDR Text Key229838000
Report Number0001825034-2021-00134
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K100238
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 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814311360
Device Lot Number633330
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 Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2019
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: 02/02/2021 Patient Sequence Number: 1
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