(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.The root cause is attributed to user error.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Territory (b)(6) reports that multiple srom reamers were damaged during a surgery with surgeon.The reamers were used to "ream" through some hardware left in a hip.Since the reamers were used to do this, many of them have been damaged and need to be replaced.No further information is available at this time.Examination of the returned reamer confirmed the complaint; the flutes on the reamer are nicked with some areas missing material.The root cause is attributed to use error.Provided information states the reamers were used to "ream" through some hardware left in a hip.Since the reamers were used to do this, many of them have been damaged and need to be replaced.Reamers are not intended to ream through metal hardware, it's intended purpose is to ream bone.The complaint sample consisted of (1) 536850 srom reamer blunt 10.5mm straight, date code a0800.The date code indicates the instrument was manufactured in august of 2000.Visual analysis found an etching of 2/17 indicating this instrument was reworked for an unknown reason in february of 2017.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.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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