Model Number 2307-92-003 |
Device Problems
Break (1069); Off-Label Use (1494)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/13/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that this was an rsa performed on (b)(6) 2022.A locking screw could not be inserted smoothly, so the surgeon used the screwdriver to insert the locking screw, as if to push the locking screw in.1 out of 4 claws at the tip of the product broke off.The surgeon did not turn the screwdriver with any particular force, but when he turned the screwdriver while pushing, one part of the tip of the screwdriver got damaged.The surgeon took out the screwdriver from the patient's body and confirmed that there were no fragments left in the patient¿s body by image intensifier.After that, the surgeon kept using the partially damaged screwdriver to insert the rest of the locking screws although the screwdriver did not engage with the locking screws enough.Eventually, tightening of the locking screws itself was completed properly.The surgery was completed successfully within 30 minutes delay.There was no harm to the patient.No further information is available.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint #(b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual analysis of the returned device confirmed the reported allegation, one of the 4 prongs on the device's tip was found broken.Also, according to the even description the health professional knowingly used the device for an indication not in the approved labeling.The report allegation can be confirmed.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
|
|