MAUDE Adverse Event Report: SYNTHES USA TI DISTAL EXTENSION SIZE 8/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.078

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: (b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).It was reported that the patient heard a popping sound and there was an unspecified malfunction of parts which required additional surgical intervention to revise the construct.Without a lot number, the device history record review and 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

(b)(6) reported the following: it was reported that a patient was implanted with a vertical expandable prosthetic titanium rib (veptr) ii system on an unknown date in (b)(6) 2009.On (b)(6) 2016, the patient underwent a scheduled lengthening procedure.On (b)(6) 2016, while the patient was running, they heard a popping sound.On (b)(6) 2016, the patient came to clinic and it was discovered on xray that something was wrong with the construct.The implanted devices were removed on (b)(6) 2016 and replaced with a magec growth rod (6.0), connected into the original veptr ii rib hook.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Partial lot number provided as 512x815.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

Upon examination of the receive devices by the manufacturer, it was noted that the proximal extension was broken and missing fragments.The remainder of the implants showed significant wear consistent with implantation and explanation but were intact.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product investigation was performed.The following device was received by customer quality (cq): one ti distal extension size 8/500mm radius (part number: 04.641.078, lot number/mfg.Date: unknown).A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The returned part was determined to be suitable for its intended use when employed and maintained as recommended.After visual inspection of this implant and based on the complaint description it was determined this part did not contribute to the complaint and therefore no further investigation is required at this time including a dcrm review.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI DISTAL EXTENSION SIZE 8/500MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6140435
• MDR Text Key: 61290933
• Report Number: 2520274-2016-15549
• 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,Followup
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.641.078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention