Catalog Number 254500508 |
Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/08/2024 |
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 the spring came off trial.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> no, did the patient require revision surgery or hardware removal? --> no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions?--> no, patient status/ outcome / consequences --> no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no, is the patient part of a clinical study --> unknown, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none, (b)(4).Device property of -->none, device in possession of -->none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
|
|
Event Description
|
Additional information received.It was noticed, at the start of surgery.That the spring was missing, so it was not used for the procedure.And an alternative was opened.
|
|
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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : according to the information received, "spring came off spacer block/dog bone and articulating surfaces.Shim doesn't click on properly, needs replacing." the product was not returned to depuy synthes, however photos were provided for review.See attachment dog bone and arc surc.Png.The photo investigation revealed that spring present around one of the post was missing and was deformed which was present around another post of attune fb ps artic surf sz8 and with present damage unable to assemble condition can be confirmed.The failure mode is consistent with inserting an extractor device in between the trial and mating shim, and using the extractor to pry the mating devices apart during extraction of the trials.This improper technique results in damage to the spring and/or post components of the articulating surface as well as the mating shim.The attune intuition surgical technique 0612-10-512 (page 53), emphasizes the correct use of the tibial trial extractor (product code 254500138) with the trials.Furthermore, on page 51 of the surgical technique and per ifu-0902-00-836, careful inspection of the trials for damage/breakage should be performed pre and post-operative.If any damage to the balseal components is observed the trail should be replaced.In the event of instrument breakage during use, ensure that all device fragments that may have entered the surgical site are removed prior to completion of the procedure, as patient injury may result.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune fb ps artic surf sz8 would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the 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
|
|