MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OXFORD FEMORAL DRILL GUIDE LATERAL IM ADAPTER; INSTRUMENT, KNEE

Model Number N/A

Device Problem Component Missing (2306)

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

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign: (b)(6).This report was previously submitted erroneously on nov 17, 2020, dec 3, 2020, dec 16, 2020 and jan 11, 2021 under manufacturing report number 3002806535-2020-00476.Upon reassessment of the reported event, it was identified to not be reportable, as the event did not result in harm to the patient and this malfunction for this type of device has not previously resulted in harm to a patient or user.Insufficient information.

Event Description

It was reported that during a knee procedure, the adapter appeared to have been missing from the set, which resulted in a sixty (60) minute delay to surgery.However, the surgery was able to be completed with another device.Attempts have been made, however, no additional information is available at this time.

• Brand Name: OXFORD FEMORAL DRILL GUIDE LATERAL IM ADAPTER
• Type of Device: INSTRUMENT, 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: 11229321
• MDR Text Key: 229901299
• Report Number: 0001825034-2021-00201
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-423400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• 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