MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION METAL IMPACTOR; ORTHOPAEDIC IMPLANT IMPACTOR, REUSABLE

Catalog Number 110029132

Device Problem Fracture (1260)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 mdr will be submitted.

Event Description

It was reported that an impactor was fractured during a procedure but no foreign bodies were retained by the patient.Attempts have been made and no additional information is available at the time of this report.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d8; e1; g1; g3; g6; h1; h2; h3; h6.The reported event is not confirmed, as the broken part is not included in the picture.Visual examination of the provided pictures identified that the tip is missing from the impactor.Medical records were not provided.A review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE INSTRUMENTATION METAL IMPACTOR
• Type of Device: ORTHOPAEDIC IMPLANT IMPACTOR, REUSABLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18905727
• MDR Text Key: 337684904
• Report Number: 0001825034-2024-00731
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304731516
• UDI-Public: (01)00880304731516(11)190625(10)608800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110029132
• Device Lot Number: 608800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1