WRIGHTS LANE: SYNTHES USA PRODUCTS LLC SPEEDSHIFT COMPRESSION IMPLANT KIT 20X20X20MM OFFSET 10MM; STAPLE, FIXATION, BONE
|
Back to Search Results |
|
Model Number SE-2020-10 |
Device Problem
Mechanical Jam (2983)
|
Patient Problems
Not Applicable (3189); No Code Available (3191)
|
Event Date 11/29/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Patient information is unknown.Device remained successfully implanted in patient.Complainant part is not expected to be returned for manufacturer review/investigation.Physical product investigation could not be completed; no conclusion could be drawn, as no product was received.Device history record: manufacturing location: synthes bme, (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that while performing a foot procedure on (b)(6) 2017, as the surgeon was placing the first staple implant, the staple did not release or separate from the insertion tool.With some difficulty, the surgeon was able to insert the first staple in the pre-drilled hole successfully.The surgeon then proceeded to insert the second staple implant and it would also not release or separate from the insertion tool.Due to additional complexity, the staple was inserted in a different hole which was created as the staple inserted itself.This procedure was completed successfully with a 3 minute surgical delay.The patient is reported to be in stable condition.Concomitant device reported: unknown insertion tool (part number unknown, lot number unknown, quantity 1).This complaint is for two (2) devices.This report is for the staple implant that reportedly required a new hole; report 1 of 2 for (b)(4).
|
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|