MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI DISTAL EXTENSION SIZE 5/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Model Number	04.641.115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 5/220mm radius.This is report 2 of 2 for complaint (b)(4).

• Brand Name: TI DISTAL EXTENSION SIZE 5/220MM RADIUS
• Common Device Name: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7129444
• Report Number: 2939274-2017-50369
• Device Sequence Number: 1256103
• Product Code: MDI
• UDI-Device Identifier: 10705034750507
• UDI-Public: (01)10705034750507(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.641.115
• Device Catalogue Number: 04.641.115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1