MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW DRILL 3.2 MM DIAMETER; PROSTHESIS, KNEE

Catalog Number 00512008500

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 0 degree distal cut block, catalog # 42509901000, lot # 63107131.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2017-08542.Reported event was unable to be confirmed due to limited information received from the customer.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.Device was discarded.

Event Description

It was reported that the drill bound up inside the distal femoral cut block during total knee surgery.This resulted "with" a fractured drill.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.

• Brand Name: BONE SCREW DRILL 3.2 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• 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: 8117626
• MDR Text Key: 128912819
• Report Number: 0001822565-2018-06654
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 00512008500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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