SMITH & NEPHEW, INC. NONRIM SPEED PIN 65 STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Catalog Number 74013480 |
Device Problems
Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/06/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
|
|
Event Description
|
It was reported that, during set up or inspection for a tka, it was found that one (1) nonrim speed pin 65 sterile was bent out of package.The procedure was performed, without any delay, using a s+n back-up device.Since incident occurred before procedure; patient was not yet involved.
|
|
Manufacturer Narrative
|
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that during set up or inspection for a tka, it was found that one (1) nonrim speed pin 65 sterile was bent out of package.The procedure was performed, without any delay, using a s+n back-up device.Since incident occurred before procedure; patient was not yet involved.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable, since there was not patient involvement.Also, the device damage did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.
|
|
Search Alerts/Recalls
|
|
|