DEPUY SYNTHES PRODUCTS LLC KINCISE AUTOMATED SURGICAL IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
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Catalog Number 1000-00-101 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 04/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Lot/serial unknown.Device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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Event Description
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It was reported that the facility recently had a small spike in surgical infections in total hip patients, as such all aspects of the surgical procedure were being examined.It was reported that the sales representative held an in-service, as requested by sterile processing department (spd) at the hospital in question, to discuss concerns about the sterilization of the surgical impactor system.It was noted that while there was no correlation in the infection incidence with the use of the impactor device, recognizing infection as a multi-factorial situation, all departments involved with hip replacement patients were looked at for ideas of areas to be investigated.It was reported that spd had misgivings about the sterilization procedure of the device.The ¿app clean process¿ was used to show evidence of residual organic material, which had evidently occurred with the impactor device after the cleaning process.It was noted that the test does not ¿show evidence of sterile or non-sterile¿.It was noted that the facility follows the instruction for use (ifu) to the letter.The facility stated ¿there does not appear to be any connection between the kincise and their slight rise in hip infections.¿ all available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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