Model Number HFD100 - ORT400 IMPERIAL |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/02/2022 |
Event Type
malfunction
|
Event Description
|
A customer reported that a torque screw in use with an hfd100 head fixation device broke apart during pinning as pressure was being applied.The customer reported no injury to the patient occurred.A second torque screw was then used in the hfd100 device, after which the surgical procedure proceeded as planned.
|
|
Manufacturer Narrative
|
The torque screw component of the hfd100 device is anticipated to return for analysis and the manufacturer is attempting to collect further detail regarding the event.A follow-up mdr will be submitted after device evaluation and investigation is complete.
|
|
Manufacturer Narrative
|
Further detailed information to support failure mode identification and root cause analysis was requested but not provided in multiple follow-up communications with the customer.Efforts were made to secure additional information and device return over the phone, in person, and over email with clinical and or/mr staff.Confirmation of the failure mode and cause of failure are not possible due to lack of information, and no device return or photos to date.Internal records were reviewed and support the device met specifications prior to the reported event.The manufacturer does not anticipate return of the component reported to break.If further reportable information becomes available a supplemental report will be filed.
|
|
Search Alerts/Recalls
|