MAUDE Adverse Event Report: . 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; SCREW, FIXATION

Model Number	47-2484-040-50
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign: (b)(6).Concomitant products: cmn femoral nail, ccd 130â°, right, 㸠11.5 mm, 21.5 cm cat: 47249321211 lot: 3049030; znnâ¿¢, cmn lag screw, 㸠10.5 mm, 110 mm including set screw cat: 47248511010 lot: 3042384.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
Event or Problem Description
It was reported that the patient underwent a right side hip nail insertion due to subtrochanteric bone fracture.It was discovered that the nail had migrated.The patient reported pain and femoral nonunion.There was no reported patient fall or false movement.The patient underwent a revision procedure to place a gtr hook plate and cerclage cable with a femoral allograft.Attempts have been made and additional information on the reported event is unavailable.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
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 or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right proximal femoral fracture fixation failure as noted with a displaced overriding alignment of the fracture site and femoral shortening and proximal migration of the hardware.Bone quality is severely osteopenic.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pain, femoral nonunion, migration of the osteosynthesis material of the right hip with the appearance of a pelvic pseudarthrosis.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not be determined.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: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): .; 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: 13618189
• Report Number: 0001825034-2022-00403
• Device Sequence Number: 14482815
• Product Code: HSB
• UDI-Device Identifier: 00889024094062
• UDI-Public: (01)00889024094062(17)300228(10)64689212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2022

1 Device was Involved in the Event

1 Patient 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: 47-2484-040-50
• Device Catalogue Number: 47248404050
• Device Lot Number: 64689212
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 04/13/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 04/11/2022; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG