MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI RIB SLEEVE-SIZE 9 220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 497.108

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient id/initials and weight are unknown.Event date: unknown.Concomitant product: it is unknown when each of the concomitant devices were added to the construct.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 europe reports an event in (b)(6) as follows: it was reported that post-operatively a lumb extension rod broke.On (b)(6) 2010, the patient who was suffering thoracic insufficiency syndrome underwent an initial surgery with vertical expandable prosthetic titanium rib (veptr) system.At that time, the fixation was performed at from right rib to lumber with hook, and from right rib to rib.The patient has undergone an extension surgery every six months.During the latest extension surgery, the complained lumb extension rod was not exchanged and it was kept using because the final fixation surgery is scheduled in (b)(6) 2017.On (b)(6) 2016, the patient went to a hospital and a doctor found the lumb extension rod was broken and unhooked at an extension part.On (b)(6) 2016, the patient was hospitalized.On (b)(6) 2016, the revision was performed successfully.All of the veptr hardware was removed and a new veptr ii was implanted without problem, no additional patient harm was reported.The surgeon commented that the issue likely occurred because the lumb extension rod in question was extended to the maximum, so it could not tolerate an active child¿s movement.Concomitant devices: closure f/extension bar tan gold (part 497.125, lot 9961805 and 7352384 quantity 2); lock f/rib support tan blue (part 497.128, lot 6882101, quantity 1); closing ½ring f/rib support tan gold (part 497.126, lot 6691726, quantity 1); cranial rib support tan gold (part 497.057, lot 7058425, quantity 1); lam-hook le tan (part 497.261, lot 6114506, quantity 1).This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 497.108, lot# 7143594.Manufacturing location: (b)(4), manufacturing date: jan 13, 2013.Component 24019 ¿ raw material, lot number 6828029.No nonconforming records were generated during production.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed for part# 497.108, lot# 7143594.The returned the extension bar is broken on one side.On the surface are some scratches visible (normal wear and tear) which however do not have an impact to the function of the implant.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.

• Brand Name: TI RIB SLEEVE-SIZE 9 220MM RADIUS
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6149319
• MDR Text Key: 61591180
• Report Number: 2530088-2016-10337
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 497.108
• Device Lot Number: 7143594
• Other Device ID Number: (01)10705034787350(10) 7143594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 PART 497.057, LOT 7058425, CRANIAL RIB SUPPORT; 1 PART 497.126, LOT 6691726, CLOSING ½RING; 1 PART 497.128, LOT 6882101, LOCK F/RIB SUPPORT; 1 PART 497.261, LOT 6114506, LAM-HOOK LE TAN; 2 PART 497.125, LOT 9961805 AND 7352384, BARS
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR