Model Number N/A |
Device Problems
Fracture (1260); Difficult or Delayed Separation (4044)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/20/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Concomitant medical devices: item# 010002718 name g7 face plate impactor size f lot # zb141101.The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported inserter bolt for g7 cup became cross threaded in the impactor plate.Upon attempts to remove bolt from plate, ball tip broke off hex driver inside the bolt.All this occurred post procedure and had no impact on surgery.The attempts to remove bolt proved useless and plate is not salvageable.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Event Description
|
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
|
|
Manufacturer Narrative
|
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
|
|
Search Alerts/Recalls
|