MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 110029132

Device Problem Crack (1135)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination of the returned product identified the tip is broken, in which a bending overload fracture failure mode was identified.Medical records were not provided.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.

Event Description

It was reported that during a surgery, the tip of the impactor cracked while impacting the glenosphere.No patient consequences were reported for this event.Attempts have been made and no further information has been provided.

• Brand Name: COMPR METAL IMPACTOR
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 17620164
• MDR Text Key: 321929687
• Report Number: 0001825034-2023-01964
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00887868470103
• UDI-Public: (01)00887868470103(11)210803(10)373190
• 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
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• 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: 373190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose