OBERDORF SYNTHES PRODUKTIONS GMBH 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number 04.037.014S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
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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) 2018, during an unknown surgery, an advanced proximal femoral nailing system (tfna) was applied for femoral trochanteric fractures.After the proximal and distal areas of the tfna nail were fixed, the surgeon tried to insert a tfna end cap into the nail using a cannulated stardrive screwdriver.However, an end cap could not be inserted into the nail completely.The surgeon tried to do this by changing an insertion angle of an end cap but could not succeed.Then, the surgeon checked and confirmed it with an unknown flexible screwdriver.The surgical wound was closed.There was a surgical delay for more than 30 minutes without patient adverse consequence.This report is for (1) tfna fem nail ø10 r 125° l235 timo15.Concomitant devices reported: cannulated stardrive screwdriver (part# 03.010.520, lot# unknown, quantity 1); unknown flexible screwdriver (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: 04.037.014s, lot: h612399.Manufaturing location: monument, manufacturing date: apr 17, 2018, expiry date: apr 01, 2028.This lot met all dimensional, visual, sterility 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.
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Event Description
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Device report from synthes reports an event in japan as follows: it was reported that on november 27, 2018, during an unknown surgery, an advanced proximal femoral nailing system (tfna) was applied for femoral trochanteric fractures.After the proximal and distal areas of the tfna nail were fixed, the surgeon tried to insert a tfna end cap into the nail using a cannulated stardrive screwdriver.However, an end cap could not be inserted into the nail completely.The surgeon tried to do this by changing an insertion angle of an end cap but could not succeed.Then, the surgeon checked and confirmed it with an unknown flexible screwdriver.Then, he retried to insert an end cap but was not successful and continued to try several times, but the problem was not fixed.He gave up doing this, and decided to leave it in partially inserted condition.The surgical wound was closed.There was a surgical delay for more than 30 minutes without patient adverse consequence and patient status was stable.Concomitant devices reported: cannulated stardrive screwdriver (part# 03.010.520, lot# unknown, quantity 1); unknown flexible screwdriver (part# unknown, lot# unknown, quantity 1).
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