Model Number 2236-00-004 |
Device Problems
Break (1069); Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/15/2022 |
Event Type
malfunction
|
Event Description
|
Inter-operatively during a total shoulder replacement, the surgeon used the apg+ 52mm sizer pin guide (223600004) on the curved handle (22300023).After placing the metaglene pin, he was not happy with the version so as he pulled back on the handle (on an angle and not in line with pin) and part of the guide got caught and did not come out.A kocker forcep was used to remove the guide.It was then noticed that part of the hexagonal prominence on the guide was missing and was found in the curved handle.The broken piece and remainder of the guide were kept separate for decontamination and return to qld warehouse with loan set.Surgeon used the apg+ 52mm +3 sizer pin guide to correct version of metaglene pin.No surgical delay.No adverse affects on the patient.
|
|
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 device confirmed the reported allegation.The device was found broken from the post, also it was reported that a unintended instrument was used to remove the guide.The overall condition of the device is heavy used.The broken part was not returned.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 (mrae) was not performed.Corrected: h3.
|
|
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.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.Corrected: h3.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the complaint.The post of the device has broken.Additionally, it was reported that a unintended instrument was used to remove the guide.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for analysis.Review of the photographic evidence confirmed the complaint.The post of the device has broken.Additionally, it was reported that a unintended instrument was used to remove the guide.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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
|