MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.5 MM T-PLATE 4 HOLES 84 MM LENGTH; PLATE, FIXATION

Catalog Number 00494500404

Device Problem Fracture (1260)

Patient Problems Non-union Bone Fracture (2369); Foreign Body In Patient (2687)

Event Date 04/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown screw (x2).G2: foreign: italy.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Reported event was confirmed by review of radiographs and medical records.Review of the available medical records identified the following: mds and part of broken screws removed, to not weaken the bone further it is decided to leave the intraosseous part of the broken screw, compression fibula osteotomy with new plate and screws, reduction and stabilization.Review of the available radiographs identified the following: initial imaging demonstrates tibial and fibular fracture fixation with 2 fractured tibial screws.Later images demonstrate hardware removal with three retained tibial screw fragments.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00327 and 0001822565-2024-01130.

Event Description

It was reported that the patient was revised due to nonunion.During the revision procedure, part of the screw was removed with a portion of it retained in the patient body.No additional patient consequences were reported.

• Brand Name: 4.5 MM T-PLATE 4 HOLES 84 MM LENGTH
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19032686
• MDR Text Key: 339248052
• Report Number: 0001822565-2024-01129
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143066
• 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: 04/03/2024

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: 00494500404
• Device Lot Number: UNKNOWN
• 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: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male