Catalog Number UNK DRILL |
Device Problems
Break (1069); Entrapment of Device (1212)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/27/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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
|
During a total knee replacement a drill pin used to secure the cutting block was removed and part of the drill pin snapped off and was left in the joint.An xray was taken and this showed the partial drill pin in the knee.It was left in and not retrieved.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.
|
|
Search Alerts/Recalls
|
|