WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 200MM - STERILE; ROD, FIXATION, INTRAMEDULLARY
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Catalog Number 04.037.213S |
Device Problems
Device-Device Incompatibility (2919); Difficult to Advance (2920)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown nail/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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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It was reported that on an unknown date the patient had an unknown procedure using a trochanteric femoral nailing advanced (tfna) system.During the surgery, while installing the tfna and approaching the intramedullary (im) canal, it was realized that the canal was too tight distally.The canal was reamed after cabling the femur to reduce a section of the fracture.After reducing the fracture with the unknown cables, the surgeon began reaming for an unknown nail and installed the nail.Then the surgeon began the proximal locking with an unknown helical blade and everything was fine.However, when the surgeon began attempting to lock distally by drilling the hole, the surgeon heard the chattering of the bone and the drill would not advanced any further.The surgeon changed the drill and drilled again, the aiming arm and insertion handle to tfna were tight and attached properly with everything in the proper location.Finally, the surgeon then removed the aiming arm and insertion handle and attempted to freehand the distal locking screw when he heard a chattering.The surgeon stop drilling and could not drill for the distal locking hole and finished without the distal locking screw.Procedure and patient status were unknown.Concomitant devices: unknown reamer (part# unknown, lot# unknown, quantity 1).Unknown cable (part# unknown, lot# unknown, quantity unknown).Unknown tfna helical blade (part# unknown, lot# unknown, quantity 1).This report is for one unknown tfna nail.This is report 1 of 6 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.H3, h4, h6 investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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 history part number: 04.037.213s, 12mm/125 deg ti cann tfna 200mm - sterile, lot number: 25p8948 (sterile), lot quantity: 6 , manufacturing location: monument, manufacturing date: 19-nov-2019, expiration date: 31-oct-2029.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16884 supplied by ethicon (abq) was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive, lot number: 21p7353, lot quantity: 199, production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended lot number: 11l3012, lot quantity: 1,000.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated 08-oct-2019 were reviewed and determined to be conforming.Part number: 04.037.912.2, lock prong, 125 degree, tfna, lot number: 3l50579, lot quantity: 95.Purchased finished goods traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00, lot number: 15l3847, lot quantity: 1,052 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated 12-jul-2019 was reviewed and determined to be conforming.Lot summary report dated 21-aug-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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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Updated event it was reported that on an unknown date, the patient had an unknown procedure using a trochanteric femoral nailing advanced (tfna) system.During the surgery, the surgeon installing the tfna and approached intramedullary (im) canal and realized the canal was too tight distally.So, the surgeon decided to ream the canal after cabling the femur to reduce a section of the fracture and after reducing the fracture with an unknown cables, the surgeon began reaming for an unknown nail and installed the nail.Then, the surgeon began the proximal locking with an unknown helical blade and everything was fine.However, when the surgeon began attempting to lock distally by drilling the hole, the surgeon heard the chattering of the bone and the drill would not advanced any further.Thus, the surgeon changed the drill and drill again and the surgeon advised to check if all aiming arm and insertion handle to tfna were tight and attached properly, and everything was in proper location.Finally, the surgeon then removed the aiming arm and insertion handle and attempted to freehand the distal locking screw.At this point, the surgeon heard a titanium chattering in which the surgeon stop drilling and could not drill for distal locking hole and was advised perfect circles with the c-arm and the surgeon said that he was going to finish up without the distal locking screw and that he was going to close up.There was a surgical delay of twenty (20) minutes.Procedure was successfully completed.Patient status was unknown.Concomitant devices reported: unknown reamer (part# unknown, lot# unknown, quantity 1); unknown cable (part# unknown, lot# unknown, quantity unknown); unknown tfna helical blade (part# unknown, lot# unknown, quantity 1), 3.2mm wire guide sleeve (part# 03.037.018, lot# unknown, quantity 1), 3.2mm trocar (part# 03.037.019, lot# unknown, quantity 1).
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