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

Model Number	47-2484-045-50
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00959, 0001822565-2023-00961.Concomitant medical products: 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head, cat: 47248403250, lot: 65613735.Unknown targeting jig.Cmn femoral nail, ccd 125â°, right, 㸠11.5 mm, 21.5 cm, cat: 47249321011, lot: 3143338.Znnâ¿¢, cmn lag screw, 㸠10.5 mm, 115 mm including set screw, cat: 47248511510, lot: 3093322.Report source: foreign: france.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 surgeon was implanting a peritrochanteric nail, after speaking with the control team during the operation, it was noted that the screws had been implanted above the nail holes.The nail was removed and replaced with another back up product during the same surgery.The surgeon is concerned that the targeting instrument had contributed to the failure.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Event or Problem Description
It was determined that the guide caused the screws to misalign and the screws did not cause or contribute to this event.The event will be investigated on medwatch #0001822565-2023-00961.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was determined that the guide caused the screws to misalign and the screws did not cause or contribute to this event.The event will be investigated on medwatch #0001822565-2023-00961.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): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16701619
• Report Number: 0001822565-2023-00960
• Device Sequence Number: 14371797
• Product Code: HSB
• UDI-Device Identifier: 00889024094116
• UDI-Public: (01)00889024094116(17)320516(10)65378233
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 47-2484-045-50
• Device Catalogue Number: 47248404550
• Device Lot Number: 65378233
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 07/24/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 04/25/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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.
• Patient Age: 42 YR
• Patient Sex: Male