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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 130 DEG 9MM X 380MM ROD, FIXATION

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ZIMMER BIOMET, INC. HFN RH 130 DEG 9MM X 380MM ROD, FIXATION Back to Search Results
Model Number 8145-09-380
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
It was reported that the patient had affixus nail implanted. Subsequently, revision procedure was performed to remove the fractured nail and external fixation was put in place.
 
Manufacturer Narrative
This event was initially reported under mfr# : 0009613350 -2021 -00301. Event date: unknown day in (b)(6) 2021. Implant date: unknown day in (b)(6) 2020. Concomitant products: cat: 814510100 lot: wg1111300a hfn lag screw 10. 5mm x 100mm. Cat: unknown screw lot: unknown. Cat: unknown screw lot: unknown. Report source: foreign- (b)(6). Product has been received by zimmer biomet and the investigation is in process. 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 - 2022 - 00848, 0001825034 - 2022 - 00849, 0001825034 - 2022 - 00850. 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 NameHFN RH 130 DEG 9MM X 380MM
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
MDR Report Key14052340
MDR Text Key288865040
Report Number0001825034-2022-00851
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number8145-09-380
Device Catalogue Number814509380
Device Lot Number973540
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/08/2022 Patient Sequence Number: 1
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