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

Catalog Number 04.641.058

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.Patient information not available for reporting.(b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Patient code (b)(4) used for: 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 1 of 3 for (b)(4).

Manufacturer Narrative

Part 04.641.058, lot 6041719: manufacturing date: april 23, 2009.The device history record (dhr) did not contain any non-conformance reports or anomalies.Dhr records for the raw material indicate the raw material underwent all require inspection and test requirements with no nonconformities reported.Review of the device history record(s) showed there were no issues during manufacture of the product that would contribute to this complaint condition.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 complaint device was received by customer quality (cq): one ti proximal extension size 8/500mm radius (part number: 04.641.058, lot number: 6041719, mfg.Date: 23apr2009).The complaint condition is confirmed.Upon visual inspection of the implant it can be seen that the under carriage of the rib sleeve portion of the proximal extension (where it mates with the distal extension) has fractured resulting in the complaint condition; the fractured portion was not returned.The balance of the device shows signs of being implanted and subsequently being removed.Replication of the complaint condition is not applicable as it¿s already broken/fractured.The complaint is confirmed for broken-post op.Drawings for the proximal extension was reviewed.The drawing was found suitable to determine the intended device design, application and dimensional conformity.The implant was found to have met the drawing specifications.A device history review was performed for all returned instruments lot number and no mrrs, ncrs or complaint-related issues were identified with the lots number which may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Please note the following complaint devices were also returned: one ti distal extension size 8/500mm radius (part number: 04.641.078, lot number/mfg.Date: unknown), one ti distraction lock (part number: 497.125, lot number: 7763886, mfg.Date: 04sep2014).After visual inspection of all the implants and based on the complaint description it was determined these parts did not contribute to the complaint and therefore no further investigation is required at this time including a dcrm review.A definite root cause for the broken proximal extension could not be determined.The observed broken proximal extension condition may have been the result of a static overload condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI PROXIMAL EXTENSION SIZE 8/500MM 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: 6140437
• MDR Text Key: 61291134
• Report Number: 2520274-2016-15548
• 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: 04.641.058
• Device Lot Number: 6041719
• 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
• Date Device Manufactured: 04/23/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention