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SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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| Catalog Number 04.037.124S |
| Device Problem
Use of Device Problem (1670)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/06/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: the investigation could not be completed; no conclusion could be drawn, as no product was received.
Based on the information available, it has been determined that no corrective and/or preventative action is proposed.
This complaint will be accounted for and monitored via post market surveillance activities.
If additional information is made available, the investigation will be updated as applicable.
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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for right trochanteric fracture.
After inserting a reaming rod into the intrathecal space, the surgeon confirmed whether the reaming rod was placed in the middle of the intrathecal space by image intensifier.
The surgeon then performed reaming with the nail and there was a slight resistance when the nail was inserted.
Hammering was also performed, and the surgeon completed the nail insertion.
When the surgeon inserted a blade and moved to the insertion procedure of a locking screw, the anterior penetration of the nail end was confirmed.
The nail was removed and replaced with another shorter nail.
The surgery was completed with a thirty (30) minute delay.
This report is for one (1) 11mm/125 deg ti cann tfna 340mm/right - sterile.
This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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The investigation could not be completed; no conclusion could be drawn, as no product was received.
Based on the information available, it has been determined that no corrective and/or preventative action is proposed.
This complaint will be accounted for and monitored via post market surveillance activities.
If additional information is made available, the investigation will be updated as applicable.
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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent open reduction internal fixation surgery for right trochanteric fracture.
After inserting a reaming rod into the intrathecal space, the surgeon confirmed whether the reaming rod was placed in the middle of the intrathecal space by image intensifier.
The surgeon then performed reaming with the nail and there was a slight resistance when the nail was inserted.
Hammering was also performed, and the surgeon completed the nail insertion.
When the surgeon inserted a blade and moved to the insertion procedure of a locking screw, the anterior penetration of the nail end was confirmed.
The nail was removed and replaced with another shorter nail.
The surgery was completed with a thirty (30) minute delay.
This report is for one (1) 11mm/125 deg ti cann tfna 340mm/right - sterile.
This is report 1 of 1 for (b)(4).
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