This is 2 of 2 reports for the 2nd device reportedly used during this event.This report is linked to mfg# 3014334038-2023-00200: the following was received via mdr report #: mw 5148233: "during surgery, while using 6" needledrivers x2, it was noticed that a 2mm piece of each needledriver missing.Search of sterile and unsterile fields.Not found.Mini c-arm imaging of surgical site, left foot was completed twice and read by surgeon as negative for each of the missing pieces.The needledrivers were obtained by clinician.No harm to patient.Ref report: mw5148232.".
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The complaint product, unknown jarit needle holder was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.Definitive root cause of the reported issue could not be determined.The issue of missing a piece may be the result of disassembly or breakage due to rough handling/environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation will be performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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