SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM; NAIL, FIXATION, BONE
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Catalog Number 212.119 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Additional product code: ktt.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 "upon arriving at the material delivered to patient by j&j voucher.It was verified from the list that the 3.5 locked screws were incomplete and in varying quantities according to the size of each screw.The vast majority of them contained only 4 units of each screw, plus a size containing only 03 units in the template, (size 28 =3 units).Only two sizes were complete which would be a total of 6 units each.Full screws were; *screw block 3.5 x24 =6 units.*screw block 3.5x40 =6 units.The sales representative was contacted and explained the situation, he informed to me that only one locked screw was missing.The surgical schedule was a bilateral procedure and that the issue of having only 4 units of each size could impact the surgery as it was a bilateral procedure and needed more of each size.When the team arrived at the operating room, the surgeon was informed of the number of screws available in the template, according to each size.The surgeon was not pleased and expressed his frustration.It was also reported that for this reason, according to he decided not to go through the operation of the left hip of the patient.The surgery was performed on the patient's right side only.If possible, standardize all of these screw templates with the same amount of screws, which would be 06 units of each.This way, future problems may be avoided with new 3.5 blocked screws shortages, specifically in surgeries that are bilateral." patient status/ outcome / consequences was only one part of the surgery was done because there was not enough material to perform the second part of the body.The surgery was bilateral.This complaint involves seventy-two (72) devices.This report is for (1) 3.5mm locking screw slf-tpng w/stardrive(tm) recess 45mm.This report is 3 of 18 for (b)(4).Related product complaint: (b)(4).
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Search Alerts/Recalls
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