STRYKER INSTRUMENTS-KALAMAZOO RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.64 X 12.6MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 0277096275 |
Device Problem
Break (1069)
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Patient Problem
Laceration(s) (1946)
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Event Date 02/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.
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Event Description
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It was reported that during a surgical procedure, the blade broke in half.It was also reported that the patient received a small cut to skin approximately 1.5 cms long as result of this event and the blade fragment was successfully retrieved from the femoral head.It was further reported that there was a short surgical delay while the surgeon opened a new blade.It was also reported that the cut was glued at the end of the case when the surgeon was closing the patient.
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Manufacturer Narrative
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The blade involved with this event was returned for evaluation and the reported failure of breakage was confirmed.Investigation results indicate that the failure was replicated using a test blade of the same catalog and lot number, while cutting in white renshape.It was concluded that the breakage was due to the application of excessive force, bending and prying.The ifu's for handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and result in tissue damage, loss of tactile control, and/or the ejection of blade fragments at a high velocity".
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Event Description
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It was reported that during a surgical procedure, the blade broke in half.It was also reported that the patient received a small cut to skin approximately 1.5cms long as result of this event and the blade fragment was successfully retrieved from the femoral head.It was further reported that there was a short surgical delay while the surgeon opened a new blade.It was also reported that the cut was glued at the end of the case when the surgeon was closing the patient.
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