MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET LO PRO SPH MILL MED; GUIDE, SURGICAL, INSTRUMENT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a lateral femoral condyle fractured during second reaming, correct surgical technique was followed, size medium flo circular cutter was used with a size 2 spigot.Fracture occurred when power tool trigger was pulled.Power tool was a stryker 7.Fractured fragment was still viable and surgeon made a clinical decision to proceed as planned and cemented femur option was used.No additional information is available at this time.

Event Description

No additional information reported.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.This event was not confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOMET LO PRO SPH MILL MED
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12252494
• MDR Text Key: 264283345
• Report Number: 0001825034-2021-02074
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-423352
• Device Lot Number: 875770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose