Initial reporter is a synthes employee a review of the receiving inspection (ri) for compressor/distractor rack was conducted identifying that lot number gm4059401 was released in a single batch on (b)(6) 2014 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A product investigation was completed: visual inspection of the complaint device showed that the rotational locking screw on secondary body is jammed and cannot be loosened.However, the pivoting sleeve was rotating freely and was not locked.Additionally, slight scratches were observed on the device but has no impact on the device functionality.No other issues were identified with the returned device.During functional test, the device was able to lock/unlock and was functioning in all the three functions, but the rotational locking screw on secondary body is jammed and cannot be loosened.The pivoting sleeve was unable to be locked even when the rotational screw was completely tightened.The jammed rotational locking screw could have caused the complaint condition.A dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to the damaged internal components or debris ingress.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
|
Device report from synthes (b)(6) reports an event as follows: during an incoming inspection at the loaner department, it was noticed that screw cannot be tightened.There was no surgery or patient impact.Visual inspection of the complaint device showed that the rotational locking screw on secondary body is jammed and cannot be loosened.However, the pivoting sleeve was rotating freely and was not locked.This report is for a viper3d compressor/distractor.This is report 1 of 1 for (b)(4).
|