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

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.

• Brand Name: HFN LH 125 DEG 11MM X 440MM
• Type of Device: 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
• MDR Text Key: 296657821
• Report Number: 0001825034-2022-01569
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887868038525
• UDI-Public: (01)00887868038525(17)270912(10)073110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male