Catalog Number A1059 |
Device Problems
Material Protrusion/Extrusion (2979); Insufficient Information (3190)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2017 |
Event Type
malfunction
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Event Description
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The hospital sent back the a1059 to the distributor to fix the device because the helicoil was protruding outwards.There was no patient involvement reported.
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Manufacturer Narrative
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Investigation completed 4/27/17.Method: -device history.Work order# (b)(4)/ lot# 151/ serial# (b)(4): the device history record for this unit shows that this part was manufactured on 03/18/2015.A total of (b)(4) were produced of this work order number and lot number.No abnormalities related to reported incident found nor were there any variances, mrr¿s or reworks associated with this work order number and lot number.No service history is on file for this device.Conclusion: in summary, the device in question was not received for evaluation after several documented attempts.Therefore, the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.
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Manufacturer Narrative
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Investigation completed 08/01/2017.Work order# 129059/ lot# 151/ serial# (b)(4).The device history record for this unit shows that this part was manufactured on 03/18/2015.No abnormalities related to reported incident were found, nor were there any variances, mrr¿s or reworks associated with this work order number and lot number.No service history is on file for this device.The customer removed the helicoil and returned the actual component (skull clamp helicoils coming off during pressure testing) that were removed from skull clamps repaired or in question.This customer sent in 21- gs127¿s (helicoils) that were removed from skull clamps repaired or in question.Due to how these helicoils were removed the heli coil threads were damaged thus we are unable to perform a dimensional inspection.Root cause is undetermined at this time.
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Search Alerts/Recalls
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