MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BUR; EXTREMITY, INSTRUMENT

Model Number 00-4501-076-00

Device Problem Fracture (1260)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported that the instrument fractured during the procedure.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

(b)(4).G2: foreign: poland.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.H3 other text: product not returned.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, g1-2, g3, g7, h1, h2, h3, h6, h10 proposed annex g code: mechanical (g04) - drill no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: BUR
• Type of Device: EXTREMITY, INSTRUMENT
• 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: 16993238
• MDR Text Key: 315853728
• Report Number: 0001822565-2023-01376
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889024271111
• UDI-Public: (01)00889024271111(17)321023(10)65495406
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K120906
• 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
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-4501-076-00
• Device Catalogue Number: 00450107600
• Device Lot Number: 65495406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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