|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the orif surgery by using the va locking screw.During screw insertion at the epiphyseal area, the surgeon could not insert the screw anymore before the screw head was about to be inserted completely.He tried to remove the screw with a driver, but the screw head got stripped.Then, he used a plier to grasp the stripped screw head, but the screw head broke.The surgeon removed the broken screw head and then suspended the surgery to wait for the removal instruments to arrive at the hospital.The surgeon waited for two (2) hours, but he decided not to use the removal instruments, because it would take more time to sterilize them.By the surgeon¿s final judgement, he left the remaining part of the broken screw in the patient¿s body and closed the incision.There was a 150-minute surgical delay.Concomitant device reported: pliers: trauma (part number unknown, lot unknown, quantity 1), screwdriver (part number unknown, lot unknown, quantity 1).This report involves one (1) 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 34mm.This is report 1 of 1 for (b)(4).
|
|
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, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.D6: device broke during insertion; device not considered implanted.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.
|
|
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, h6: a product investigation was conducted: investigation selection investigation site: cq zuchwil selected flow(s): device interaction/functional and damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: upon visual inspection of the complaint device it can be seen that we only have received two (2) pieces of the screw head, those pieces are badly damaged(broken) all over, this thus confirming the complaint description.In addition, the shank part of the screw is missing as reported.(b)(4).Functional test: the relevant features are deformed in a manner which prevents accurate functional test.Dimensional inspection: the relevant features are deformed in a manner which prevents accurate dimensional inspection.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot 1l57993.All relevant features are defined on the used drawing revisions of dhr of production lot 1l57993.Summary: the review of the production history revealed that this item was manufactured in july 2018 according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.Unfortunately, we are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place or/and that high applied mechanical force could have led to this damage.To prevent such problems, it is necessary to operate according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part: 04.211.034s, lot: 1l57993, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: sept 20, 2018, expiry date: sept 01, 2028.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part 04.211.034, lot h687557, manufacturing site: monument, release to warehouse date: july 26, 2018.Manufacturing location: monument manufacturing date: jul 16, 2018, part number: 04.211.034, 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 34mm, lot number: h687557 (non-sterile), lot quantity: 236.One piece was scrapped in cell at op #20, turn/thread head, flute, after being dropped.Work order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in process / inspect dimensional / final inspection, ns049907 rev n met all inspection acceptance criteria.Packaging label log (pll) lmd rev ab was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 04.211.034.999, 2.8mm ti screw blank 34mm 02.7 variable angle w/sd8, lot number: h398502, lot quantity: 960.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process dimensional, n070568 rev c met all inspection acceptance criteria.Part number: 04.210.132.999, 2.8mm screw blank 41.5mmno head turn/no point w/sd8, lot number: h395241, lot quantity: 960.Work order traveler met all inspection acceptance criteria.Part number: 23032, tialnbci2.78, lot number: 7229232, lot quantity: 797 lbs.Product traveler met all inspection acceptance criteria.Product certification supplied by dynamet dated jan 14, 2013 was reviewed and determined to be conforming.Lot summary report dated jan 24, 2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review jun 18, 2020: dhr reviewed.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.
|
