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
Medical Device Problem Code	Migration (4003)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0001822565-2022-00723
• Device Sequence Number: 3837099
• Product Code: HSB
• UDI-Device Identifier: 00889024094017
• UDI-Public: (01)00889024094017(17)301019(10)64917325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A