Model Number 420918 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/22/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the metal saw capture in trumatch came out of guide.
|
|
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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 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.
|
|
Event Description
|
Additional information received: a.Was there a surgical delay? if yes, what is the duration of the delay? no delay.B.Was/were there any adverse consequence/s that affected the patient because of the reported event? no adverse consequences.C.Please clarify if the instrument broke into two or more pieces? if no, please specify what is the alleged deficiency of the instrument.Is it bent, cracked, stripped, worn or cross threaded? metal cutting shim slid out a little from the trumatch block.D.What saw blade was used during the procedure at the time of the event? please provide as much product details of the saw blade including was it a competitor saw blade used? brassler 3 hole narrow saw blade.E.If the saw blade was a jnj product, please confirm if additional product info is available.Not a jnj product.F.Was the same saw blade used in multiple procedures? sawblade used only once.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary - the device associated with the reported event was not returned for evaluation.The investigation could not confirm the reported event.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.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
|
|