MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR AUG MINI REAMER 20 DEG; BONE-RESECTION ORTHOPAEDIC REAMER, REUSABLE

Catalog Number 110040420

Device Problem Naturally Worn (2988)

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

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Common device name: phx.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the augment reamer was dull and not cutting properly.Additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - drill.Visual examination of the returned product verified item and lot numbers.Cosmetic inspection of the product found nicks, scratches, faded etching and wear marks.Inspection of the cutting flutes found damages; worn, deformed and gouged.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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: COMPR AUG MINI REAMER 20 DEG
• Type of Device: BONE-RESECTION ORTHOPAEDIC REAMER, 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: 15266765
• MDR Text Key: 305538276
• Report Number: 0001825034-2022-01901
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304811171
• UDI-Public: (01)00880304811171(11)180412(10)697510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172502
• 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: 09/15/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 110040420
• Device Lot Number: 697510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2018
• 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
• Patient Sex: Male