It was reported that several devices were discovered to be broken or damaged during sterile processing.The needle for three (3) depth gauges for 2.0mm and 2.4mm screws had broken off.Additionally, it was discovered that the head pieces and collars were missing from two other devices (depth gauges for 2.7mm and small screws and depth gauges for large screws).The events did not occur during a procedure and, therefore, resulted in no patient harm or surgical delay.This report is 2 of 5 for (b)(4).
|
Additional narrative: service history review: lot 6770210: no service history review can be performed as this is a lot controlled item.The service history evaluation is unconfirmed.A service and repair evaluation was completed: the customer reported the needle broke off.The repair technician reported tip broken as the reason for repair.The item is not repairable.The cause of the issue is unknown.This item was forwarded to the complaint handling unit.The evaluation was confirmed.A product investigation was completed: depth gauge-1 (part 319.01 | lot 8080549 | manufacture date: 10/2012); depth gauge-2 (part 319.006 | lot 6138150 | manufacture date: 05/2009); depth gauge-3 (part 319.006 | lot 6770210 | manufacture date: 09/2011); depth gauge-4 (part 319.006 | lot 7151460 | manufacture date: 09/2013)the returned depth gauges show signs of regular usage, with various scratches and marks.Guage-1 has no functional damage but is missing the headpiece/pin assembly.Component was most likely lost during sterile processing.Remaining devices (gauge-2, guage-3, and guage-4) have the measuring needle broken off at their interface to the black graduated rod.This damage most likely occurred during sterile processing.A visual inspection, dimensional inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.This complaint is confirmed.The drawing for the device(s) were reviewed.No drawing issues or discrepancies were noted.The designs are adequate for their intended use and did not contribute to this complaint condition.The returned instrument(s) are additional instruments used during implantations to measure screw sizes and proper use and maintenance are addressed in numerous technique guides.Although the exact cause cannot be determined, this complaint condition is possibly a result of method of use and inattentiveness during sterilization.An inspection of the returned components showed no design issues.The returned part(s) are determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, but the design of the device did not contribute to this complaint.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.
|
Additional narrative: event date: unknown.Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be completed.The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the service history records has been requested and is pending completion.Device 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.
|