SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 55MM; NAIL,FIXATION,BONE
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Catalog Number 212.123 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional procode: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, eighteen (18) locking screws were found to have incorrect quantities in the packaging.The packing is meant to contain six units but the affected packing only contained three or four units.The issue was found before the procedure.The implants were intended for a bilateral hip procedure.Due to the shortage of screws, the surgeon decided to operate on the patient's right side only.There is no further information available.This report is for one (1) 3.5mm locking screw slf-tpng w/stardrive(tm) recess 55mm.This is report 8 of 18 for (b)(4).This complaint is linked to (b)(4).
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Search Alerts/Recalls
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