MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL TI RIB HOOK; PROSTHESIS, RIB REPLACEMENT

Model Number 04.641.002

Device Problem Material Twisted/Bent (2981)

Patient Problem Not Applicable (3189)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

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.Visual nonconformity (black spot on surface of hook) for two parts.Feature d2 go side of gage binds when entering hole.Feature l2 go side of gage binds when passing through opening.The parts were 100% inspected all nonconforming parts were scrapped.The conforming parts were moved on to the balance of the manufacturing operations.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 three (3) 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.

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.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 three (3) devices.This report is 3 of 3 for (b)(4).

• Brand Name: SMALL TI RIB HOOK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9578813
• MDR Text Key: 190636657
• Report Number: 2939274-2020-00142
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 10705034749839
• UDI-Public: (01)10705034749839
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.641.002
• Device Catalogue Number: 04.641.002
• Device Lot Number: 7365434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1