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

Model Number	8144-11-440
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.

• Brand Name: HFN LH 125 DEG 11MM X 440MM
• Common Device Name: ROD, 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 Key: 14936190
• Report Number: 0001825034-2022-01569
• Device Sequence Number: 17418118
• Product Code: HSB
• UDI-Device Identifier: 00887868038525
• UDI-Public: (01)00887868038525(17)270912(10)073110
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8144-11-440
• Device Catalogue Number: 814411440
• Device Lot Number: 073110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male