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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LH 125 DEG 11MM X 440MM ROD, FIXATION

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ZIMMER BIOMET, INC. HFN LH 125 DEG 11MM X 440MM ROD, FIXATION Back to Search Results
Model Number 8144-11-440
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2022
Event Type  malfunction  
Event Description
It was reported that the nail did not properly assemble to the jig. No adverse events have been reported as a result of the malfunction. Attempts have been made. Additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). Visual examination of the returned targeting jig shows minimal signs of wear in the form of scuffing on the adjustment knob. The bolt hole of the jig has four (4) severe nicks along the outside edge. There are no signs of damage where the jig bolt seats into the insertion jig. The jig bolt shows no signs of damage, aside from worn etch. The nail was not returned. Review of the device history record(s) identified no deviations or anomalies during manufacturing. Root cause was unable to 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 NameHFN LH 125 DEG 11MM X 440MM
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key14936190
MDR Text Key296657821
Report Number0001825034-2022-01569
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8144-11-440
Device Catalogue Number814411440
Device Lot Number073110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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