It was reported that the 3.0 mm ti cannulated screw instrument and implant set (p/n 145.17) was submerged in water after a storm, (b)(6).The sales consultant¿s car and the set were completely under water for a few hours, possibly longer; subsequently, the set was soaked.Sales consultant also mentioned that when he looked inside the set there was sand/sediment/mud and remembers some oxidation/rust on parts of the set (he couldn¿t be specific).The set was supposed to be set aside to be disposed of but was inadvertently missed.When returned to the synthes facility, the set was decontaminated and sent out to be used by a hospital.Reportedly the first time it was shipped out, the set was not used and was sent back unused.The set was then decontaminated again when it was returned and eventually sent out to a hospital where it was used.The set was returned and used 4 times total after being involved in the hurricane.Per an order report from (b)(4) 2013, fourteen devices (parts 292.622, 314.465, 402.620, 402.624, 292.623, 402.618, 402.632 and 402.732) were billed for usage and used on a patient.This report is 9 of 14 for (b)(4).
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This device was used for treatment, not diagnosis.Date of event unknown.The following parts are also included in the set.Synthes cannot identify whether or not they were used during the procedure with the patient: (b)(4).Device is an instrument and is not implanted / explanted.Device was received for evaluation (date unspecified).Investigation is on-going.Subject device has been received and is currently in the evaluation process.No conclusion can be drawn.Review of manufacturing records has been requested.Residual testing was performed on the set.The results showed on (b)(4) 2014 that the implants are cytotoxic and furthermore some non-volatile materials (yet to be identified) also are being identified.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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