MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTAL EXTENSION SIZE 11/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.121

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Exact date of post-operative breakage is unknown; however, confirmation of breakage occurred during an er visit on (b)(6) 2016.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: february 6, 2009.The lot was produced with no non-conformance reports generated or anomalies noted.A total of (b)(4) lot pieces were accepted and released.A review of the raw material records was also conducted: the raw material was received at the (b)(4) facility and underwent all required inspection and test requirements with no non-conformities reported.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device 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

It was reported that a patient was originally implanted with a vertical expandable prosthetic titanium rib ii (veptr-ii) construct on (b)(6) 2012 in order to treat a diagnosis of soto syndrome and scoliosis.On an unknown date, the patient was bending over and felt significant pain on the left side of the back.X-ray images taken in the emergency room revealed that the distal extension was broken just below the rib sleeve (noted to be the distal extension rod on the left side).On (b)(6) 2016, the patient was taken to surgery to have the broken implant removed.Following the successfully extraction, the patient was revised to a new device.The procedure was completed with no reports of delay or additional medical intervention.Concomitant device(s) reported: titanium extraction lock (part: 497.125 / lot: 6903614 / quantity: 1) and a titanium proximal extension (part: 04.641.101 / lot: 606530 / quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the following complainant device was received for investigation: one (1) ti distal extension size 11/220mm radius (part: 04.641.121 / lot: 5893777).A visual inspection and drawing 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.The complaint condition is confirmed.Note: the ti extraction lock (part: 497.125 / lot: 6903614) and the ti proximal extension (part: 04.641.101 / lot: 6065304) were also returned as a concomitant devices without alleged complaints.Upon visual inspection of both devices, there was no evidence indicating that they had contributed to the complaint condition reported.Therefore, no additional investigation will be performed on this device.However, it did appear that the proximal extension had been cut during the surgery ¿ likely to fit to the patient¿s anatomy.The returned complainant device is part the depuy synthes veptr ii system.The veptr ii device is designed to mechanically stabilize and distract the thorax to correct three dimensional thoracic deformities and provide improvement in volume for respiration and lung growth in infantile and juvenile patients diagnosed with thoracic insufficiency syndrome.The veptr ii devices are either attached perpendicular to the patient¿s natural ribs or to the lumbar vertebra or ilium.Upon visual inspection, the complaint condition is confirmed as there is a transverse fracture right at the implant¿s etching.The fracture occurred approximately 19.98 mm below the most distal hole.Additionally, the distal end of the device appears to have been cut (approximately 40-42mm per drawing) and contoured, most likely during the original surgery to accommodate for the patient¿s anatomy.A review of the current design and available history for the top level drawing for the instrument was performed.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended uses when employed and maintained as recommended.A definitive root cause could not be determined; however, the type of fracture may have been the result of a static overload condition as stated in the complaint description.Device 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 DISTAL EXTENSION SIZE 11/220MM 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5790125
• MDR Text Key: 49406823
• Report Number: 2530088-2016-10189
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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: 04.641.121
• Device Lot Number: 5893777
• Other Device ID Number: (01)10705034750569(10)5893777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50