MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR CENTER POST REAMER; GLENOID ORTHOPAEDIC REAMER

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

It was reported that the reamer was fractured during use, as the reaming end was damaged and split.No further event information is available at the time of this report.

Manufacturer Narrative

(b)(4).Component code: mechanical ((b)(4)) ¿ drill.Visual examination of the returned product identified the cutting feature is split / damaged.Material hardness is conforming to print specifications.The device exhibits wear & tear that indicates repeated use.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: MODULAR CENTER POST REAMER
• Type of Device: GLENOID ORTHOPAEDIC REAMER
• 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: 15931925
• MDR Text Key: 307687607
• Report Number: 0001825034-2022-02694
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024574779
• UDI-Public: (01)00889024574779(10)64808627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191814
• 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
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SBGL3007
• Device Lot Number: 64808627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2020
• 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