MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 3-IN-1 IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 110028055

Device Problem Fracture (1260)

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

Event Date 09/07/2023

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.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 after being used in a procedure, the grey tip of the impactor was found split in half after washing/decontamination.No pieces were left in the patient and the patient did not experience any harm as a result of the event.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided photograph identified that the tip of the impactor is broken.Further analysis of the impactor tip could not be performed as the pad was not returned.Part 110028055 is supposed to have a black tip, however, this instrument was pictured with a grey tip assembled.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.The tip of the impactor switched is epoxied, and therefore not to be disassembled for sterilization.However, it is unknown if this contributed to the reported event.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report 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: COMPR 3-IN-1 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: 17868751
• MDR Text Key: 324898947
• Report Number: 0001825034-2023-02272
• Device Sequence Number: 1
• Product Code: PHX
• 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: 01/09/2024

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: 110028055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female