MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR METAL IMPACTOR; INSTRUMENT, EXTREMITIES

Model Number N/A

Device Problems Degraded (1153); Fracture (1260); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product code: phx.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.

Event Description

It was reported upon receiving we found this part with the grey tip was cross threaded and some threads broken off.This part is not made to be removed.Attempts have been made and no further information has been provided.

Event Description

Upon receipt of additional information, it has been determined that this is not a reportable event.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to use error.The impactor handle and tip are assembled together using medical grade epoxy.The impactor tip is not meant to be removed.Visual examination of the returned product identified the threads on the impactor pad have been damaged.The impactor pad is not meant to be removed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Upon receipt of additional information, it has been determined that this is not a reportable event.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report was forwarded in error and should be voided.

• Brand Name: COMPR METAL IMPACTOR
• Type of Device: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11771296
• MDR Text Key: 251483707
• Report Number: 0001825034-2021-01354
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304731516
• UDI-Public: (01)00880304731516(11)200821(10)477100
• Combination Product (y/n): N
• PMA/PMN Number: K193373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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 Model Number: N/A
• Device Catalogue Number: 110029132
• Device Lot Number: 477100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1