MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW; SCREW, FIXATION

Model Number	47-2484-050-60
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).5.0 mm diameter cortical screw cat: 47248404050 lot: 64677063.5.0 mm diameter cortical screw cat: 47248404550 lot: 64581106.Greater trochanter femoral nail cat: 47249232011 lot: 62451700.Foreign: (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that approximately 8 months post implantation, the patient experienced a fracture and the implanted nail had also fractured and become loose.The patient was revised.No further information has been provided.
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.Visual examination of the returned products identified the screws were scratched and gouged.The nail had heavy scratches and gouges and was fractured.The nail was submitted for further analysis.Analysis determined the fracture was due to fatigue.The material is consistent with specifications.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the x-ray dated (b)(6) 2020 showed an intramedullary rod with 2 screws and 3 cerclage wires.Faint linear lucency was noted along the anterior cortex of the mid diaphysis of the femur extending proximally from the most proximal cerclage wire.The x-ray dated (b)(6) 2020 showed an intramedullary rod with 1 proximal and 2 distal screws for an oblique fracture of the distal diaphysis medical cortex, along with 3 cerclage wires.X-rays on (b)(6) 2021 showed a comminuted fracture of the distal diaphysis of the femur with radiolucency surrounding the intramedullary rod and the distal screws as well as the cerclage wires consistent with bony fracture and hardware loosening.There is fracture of the distal intramedullary rod.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: 6.0 MM DIAMETER CANCELLOUS SCREW
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11313426
• Report Number: 0001822565-2021-00371
• Device Sequence Number: 14472633
• Product Code: HSB
• UDI-Device Identifier: 00889024094178
• UDI-Public: (01)00889024094178
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 47-2484-050-60
• Device Catalogue Number: 47248405060
• Device Lot Number: 64466394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 60