MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LAG SCREW INSERTER; INSTRUMENT/TRAUMA

Catalog Number 27990

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that during a patient's revision surgery while using the instrument to remove the implant, the instrument fractured.The surgeon was unable to remove the implant and caused a surgical delay of two (2) hours.The revision surgery was not completed, and a new revision surgery was to be scheduled on an unknown date.

Manufacturer Narrative

(b)(4).Report source: foreign: costa rica.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Visual examination of the provided pictures identified the tip of the inserter is fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: intramedullary nail and screw fixation is present for femoral neck fracture fixation.The hardware is intact.The fracture appears healed.There is a large osseous fragment medial to the femoral neck.There is narrowing of the superior hip joint space.A definitive root cause cannot 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: LAG SCREW INSERTER
• Type of Device: INSTRUMENT/TRAUMA
• 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: 19043759
• MDR Text Key: 340113313
• Report Number: 0001825034-2024-00950
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 27990
• Device Lot Number: 182730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female