Catalog Number 254400522 |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/22/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the surgeon was pinning the distal femoral block and started putting the pin in at an angle.The pin became stuck in the cutting block.Staff opened another cutting block and the rest of the case proceeded as normal.There was no issue to the patient.A total of less than one minute delay was observed.A portion of the pin did break in spd after the case when the staff tried to remove the pin from the block.There were no pieces broken intra op, and therefore no pieces to retrieve from the patient.The block is being returned with the pin cold welded in it.
|
|
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.
|
|
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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: it was reported that the surgeon was pinning the distal femoral block and started putting the pin in at an angle.The pin became stuck in the cutting block.Staff opened another cutting block and the rest of the case proceeded as normal.There was no issue to the patient.A total of less than one minute delay was observed.A portion of the pin did break in spd after the case when the staff tried to remove the pin from the block.There were no pieces broken intra op, and therefore no pieces to retrieve from the patient.The block is being returned with the pin cold welded in it.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found the attune distal fem cut block has stuck inside at one of the insertion holes an unknown fixation pin.The observed condition of the device was consistent with off axis insertion.A functional test was performed and was able to replicate the reported condition due to the devices do not disengage as intended.A dimensional inspection was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the attune distal fem cut block would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|
|