This complaint is confirmed as the device was received damaged.
The user is reported to have damaged the complaint device.
There was no indication that a design or manufacturing issue contributed to the complaint.
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 history lot: part number: 03.
037.
024, lot number: t145415, manufacturing site: (b)(4), release to warehouse date: 15-mar-2017.
A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.
Device history batch: null.
Device history review: null.
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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It was reported that on an unknown date, during hip surgery, the surgeon had a helical blade stuck in a nail and had to damage instruments to get it out.
There was a surgical delay of forty-five (45) minutes.
The procedure was successfully completed.
Patient status is unknown.
Concomitant devices reported: helical blade (part # unknown, lot # unknown, quantity 1), helical blade inserter (part # 03.
037.
024, lot # t145415, quantity 1), helical blade/screw coupling screw (part # 03.
037.
026, lot # l234221, quantity 1), 130 degree aiming arm (part # 03.
037.
013, lot #l282383, quantity 1), blade/screw guide sleeve (part # 03.
037.
017, lot # l274027, quantity 1).
This report is for one (1) helical blade inserter.
This is report 3 of 3 for (b)(4).
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