MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI RIB HOOK; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.001

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).A device history records review has been requested and is pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Canada reported the following event: it was reported that during vertical expandable prosthetic titanium rib ii (veptr ii) revision surgery performed on (b)(6) 2016 there were several issues.During implantation, the locking mechanism on the rib hook broke off when using the t-handle torque wrench and the head of the screw on the rib hook (screw is the part of the rib hook) fragmented and retrieved without intervention.A spare device was readily available to complete the procedure.Also, there was an issue with the distraction locking caps.Four of the distraction locking caps were not fitting properly and were loosely connecting to the rib hook and rib cap.Surgeon also had concerns over the amount of movement or play the three (3) rib hook caps had when locked with the distraction locking cap.The surgeon reported that they were jiggling little extra than expected.The surgeon, however, decided to keep the same rib hook caps and completed the implantation of the devices.The surgery was prolonged for 45 minutes due to the reported issues.No additional medical intervention was required and the surgery was completed successfully.The patient's status was reported as stable after the surgery.The post-operative veptr ii revision surgery was performed as the part of the planned treatment and also due to previous rib hook had migrated from the rib.This postoperative event is captured in complaint (b)(4).This report addresses the issues with the rib hook locking mechanism and associated screw component only.This device was not implanted due to the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Manufacturing date: february 09, 2009.Review of the device history records (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Dhr records for the raw material lot further indicate that the raw material underwent all required inspection and test requirements with no non-conformities related to the complaint condition reported.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Concomitant device reported as: t-handle torque wrench (part/lot unknown, quantity 1); rib hook (part/lot unknown, quantity 3).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Manufacturing and product development investigations were performed for the subject device (ti rib hook, part number 04.641.001, lot number 6080685).The vertical expandable prosthetic titanium rib (veptr) ii system is designed to ¿mechanically stabilize and distract the thorax to correct three-dimensional thoracic deformities and provide improvement in volume for respiration and lung growth in infantile and juvenile patients diagnosed and or at risk of developing thoracic insufficiency syndrome¿ per the technique guide.Within the system, the rib hook (04.641.001-2) attaches to the hook cap and proximal extension to support the superior rib, or the distal extension to support the inferior rib.The hook cap (04.641.004-9) attaches to the rib hook to encircle the superior or inferior rib and the distraction lock (497.125) connects the components (rib hook to hook cap, rib hook to rib hook extension, proximal extension to distal extension¿etc.).Product drawings including: top level, rib hook body, barrel and nut were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was forwarded to (b)(4) for manufacturing investigation where the complaint was able to be confirmed for the rib hook but was determined to be post-manufacturing damage.The rib hook was returned with the threads of the barrel broken and stuck inside the nut.The rib hook body exhibited visible scratches and discoloration throughout the device.Although the definitive root cause cannot be determined with the provided information, it is likely that the damage to the interface of the distraction lock and rib hook contributed to the complaint condition of loose and excessive force may have contributed to the complaint condition of broken for the rib hook.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI RIB HOOK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5957276
• MDR Text Key: 55002949
• Report Number: 2530088-2016-10246
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.001
• Device Lot Number: 6080685
• Other Device ID Number: (01)10705034749822(10)6080685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1