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 47-2484-032-50

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00960, 0001822565-2023-00961.Concomitant medical products: 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head cat: 47248404550, lot: 65378233.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 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.

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 Description

No further event information available at the time of this report.

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.

Event 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.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• Type of Device: 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: 16701625
• MDR Text Key: 312891111
• Report Number: 0001822565-2023-00959
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024093997
• UDI-Public: (01)00889024093997(17)321010(10)65613735
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47-2484-032-50
• Device Catalogue Number: 47248403250
• Device Lot Number: 65613735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male