MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW RED - FIXED ANGLE 3.5MM HEAD; ROD, FIXATION

Model Number N/A

Device Problem Migration (4003)

Event Date 07/19/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent removal of a screw that had backed out approximately four months following a leg fixation procedure.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

(b)(4).It is unknown which screw backed out from the list of screws reported and included within concomitant products.It could be one of the following: zimmer natural nail 5.0mm diameter cortical screw red - fixed angle 3.5mm hex head catalog #: 47248403550 lot #: 64917325.Manufacture date: oct 26, 2020; sterile expiration date: oct 19, 2030 udi #: ((b)(4).Zimmer natural nail 5.0mm diameter cortical screw red - fixed angle 3.5mm hex head catalog #: 47248404050 lot #: 64875678.Manufacture date: sep 16, 2020; sterile expiration date: sep 8, 2030 udi #: (b)(4).Zimmer natural nail 5.0mm diameter cortical screw red - fixed angle 3.5mm hex head catalog #: 47248403750 lot #: 64358209.Manufacture date: mar 25, 2019; sterile expiration date: mar 31, 2029 udi #: (b)(4).Zimmer natural nail 6.0mm diameter cancellous screw 3.5mm hex head catalog #: 47248310060 lot #: 62803102.Manufacture date: sep 22, 2014; sterile expiration date: sep 30, 2024.Zimmer natural nail 6.0mm diameter cancellous screw 3.5mm hex head catalog #: 47248309560 lot #: 64543973.Manufacture date: sep 27, 2019; sterile expiration date: sep 30, 2029 udi #: (b)(4).Concomitant medical products: concomitant devices -zimmer natural nail 5.0mm diameter cortical screw red - fixed angle 3.5mm hex head catalog #: 47248404050 lot #: 64875678, zimmer natural nail 5.0mm diameter cortical screw red - fixed angle 3.5mm hex head catalog #: 47248403750 lot #: 64358209, zimmer natural nail 6.0mm diameter cancellous screw 3.5mm hex head catalog #: 47248310060, lot #: 62803102, zimmer natural nail 6.0mm diameter cancellous screw 3.5mm hex head catalog #: 47248309560 lot #: 64543973, zimmer natural nail greater trochanter femoral nail green left 10mm diameter 34cm length catalog #: 47249234110, lot #: 64578370, antegrade femoral nail cap 10mm catalog #: 47248700110, lot #: 63978732.Report source - foreign: (b)(6).The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.

• Brand Name: ZIMMER NATURAL NAIL 5.0MM DIAMETER CORTICAL SCREW RED - FIXED ANGLE 3.5MM HEAD
• 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: 13769881
• MDR Text Key: 287258259
• Report Number: 0001822565-2022-00723
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024094017
• UDI-Public: (01)00889024094017(17)301019(10)64917325
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Report Date: 03/15/2022

1 Device was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47248403550
• Device Lot Number: 64917325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A