MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN AFFIXUS NAIL; ROD, FIXATION

Catalog Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.The root cause is determined to be an off-label use.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.

Event Description

It was reported that the incorrect sided nail was implanted.The device was exchanged for the correct implant.No harm to patient reported.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN AFFIXUS NAIL
• Type of Device: ROD, FIXATION
• 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: 9903450
• MDR Text Key: 188862657
• Report Number: 0001825034-2020-01407
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2019
• 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