Product complaint # (b)(4).Device returned.A review of the device history record.Device history lot: part number: 04.641.002, lot number: 7365434, part manufacture date: 04/22/2013, place of manufacture: brandywine, part expiration date: n/a.Dhr record review: a review of the device history records revealed one non-conformance report, these non-conformance's are not relevant to the complaint.According to the product complaint ¿the hex coupling nuts of three (3) small titanium (ti) rib hook were stripped.¿ features (d2 and l2) are the hole where the rod fits into the body.An undersized hole would have caused the rod not to fit into the assembly not bind the nuts.Investigation summary background: 12/23/2019 updated event description.It was reported that on (b)(6) 2019, during a bilateral revision of superior cradle surgery with the vertical expandable prosthetic titanium rib (veptr), the hex coupling nuts of three (3) small titanium (ti) rib hook were stripped.Originally, the patient was implanted on an unknown date.The small titanium rib hooks were the choice of implants for replacement bilaterally.However, upon final tightening using an unknown 5nm torque limiting handle with an unknown veptr nut driver shaft, the 6mm hex coupling of the small rib hooks were not achieved and were believed that the hex coupling nuts of the small rib hooks were stripped.The final tightening was finally achieved after switching out the three small titanium rib hooks.All implants needed to be removed were removed successfully.There was a surgical delay of 30 minutes.The surgery was completed with no adverse consequence to the patient.Concomitant devices reported: unknown torque limiting handle (part# unknown, lot# unknown, quantity# 1), unknown veptr nut driver shaft (part# unknown, lot# unknown, quantity# 1), rib hook cap (part# 04.641.007 lot #: 7404508, quantity# 1), unknown closure for extension bar (part# unknown, lot# unknown, quantity# unknown), unknown proximal extension bar (part# unknown, lot# unknown, quantity# unknown), unknown distal extension (part# unknown, lot# unknown, quantity# unknown), unknown parallel connector (part# unknown, lot# unknown, quantity# unknown), unknown ala hook (part# unknown, lot# unknown, quantity# unknown).This complaint involves two (2) devices.Investigation flow: damage.Visual inspection: small ti rib hook (quantity: 2) were received at us cq.Upon visual inspection at cq, it is observed that the threads of the barrel and external part of the nut were stripped in both the devices.The rest of the surfaces of both the devices shows minimal wear which would not contribute to the complaint condition.Thus, the reported stripped condition is being confirmed.Device failure/ defect found.Dimensional inspection: dimensional inspection of the received devices was not performed due to post manufacturing damage.Documentation/ specification review: the following drawing(s) was reviewed; -small rib hook veptr ii: 04_641_002 rev.B and rev.F.No design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, and document specification review of the received device was performed at cq.The complaint is being confirmed as it is observed that the threads of the barrel and external part of the nut were stripped in both the devices.While a definitive root cause could not be determined, it is possible that the devices might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.
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It was reported that on (b)(6) 2019, during a bilateral revision of superior cradle surgery with the vertical expandable prosthetic titanium rib (veptr), the hex coupling nuts of three (3) small titanium (ti) rib hook were stripped.Originally, the patient was implanted on an unknown date.The small titanium rib hooks were the choice of implants for replacement bilaterally.However, upon final tightening using an unknown 5nm torque limiting handle with an unknown veptr nut driver shaft, the 6mm hex coupling of the small rib hooks were not achieved and were believed that the hex coupling nuts of the small rib hooks were stripped.The final tightening was finally achieved after switching out the three small titanium rib hooks.There was a surgical delay of 30 minutes.Procedure and patient outcome are unknown.Concomitant devices reported: unknown torque limiting handle (part# unknown, lot# unknown, quantity# 1), unknown veptr nut driver shaft (part# unknown, lot# unknown, quantity# 1), unknown rib hook cap (part# unknown, lot# unknown, quantity# unknown), unknown closure for extension bar (part# unknown, lot# unknown, quantity# unknown), unknown extension bar (part# unknown, lot# unknown, quantity# unknown).This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
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