MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI DISTAL EXTENSION SIZE 4/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Model Number 04.641.114

Device Problem Break (1069)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that two distal 220mm vertical expandable prosthetic titanium rib ii (veptr ii) size 4 and size 5 rods broke when the surgeon was bending the rods to contour them as per the size of the patient¿s rib cage during a thoracic surgery.The patient came in for a planned revision on (b)(6) 2017 to expand and adjust the rods.While contouring the new rods, they broke towards the expansion point where it converts to the rectangle shape.The rods broke when the surgeon was bending it with the aid of a rod bender outside the patient.The breakage occurred in situ.The procedure was completed successfully with the help of other readily available rods from the sets.There was 60 minutes of surgical delay reported to complete the procedure and the patient outcome was reported to be fine.Lateral rib hook and distal 220 rod was explanted during hardware removal.Concomitant device (s) reported: rod bender (unknown part and lot number, unknown quantity).This report is for one (1) ti distal extension size 4/220mm radius.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TI DISTAL EXTENSION SIZE 4/220MM RADIUS
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7129424
• MDR Text Key: 95743294
• Report Number: 2939274-2017-50368
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 10705034750491
• UDI-Public: (01)10705034750491(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.641.114
• Device Catalogue Number: 04.641.114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1