Catalog Number 130790042 |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
It was reported that this was an unknown surgery performed on (b)(6) 2024.The locking screw in question was used for metaglene fixation.When the screwdriver was turned for locking, the inside part came off and could not be locked.It was removed from the body, and a new screw with same size was used for surgery.There was no surgical delay and no harm to the patient.No further information is available.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|