MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI DISTAL EXTENSION SIZE 13/220MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Catalog Number 04.641.123

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Exact date of post-operative breakage is unknown; however, it was discovered via x-ray on (b)(6) 2016.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: november 14, 2013.Synthes lot 7508190 did not contain any non-conformance reports (ncr) or anomalies.All fourteen (14) pieces were accepted as conforming.The supplier lot (7167520) was also reviewed: the device history record (dhr) for the raw material indicated that the raw material was received at the (b)(4) facility in april, 2013.The dhr records further indicate that the raw material underwent all required inspection and test requirements with no non- conformities reported.No issues were identified 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 vertical expandable prosthetic titanium rib (veptr) distal rib extension broke at the rod/sleeve junction.The patient was reportedly bent over while weight bearing when a popping sensation and pain were felt.At the emergency room (er), x-rays confirmed that the distal rib extension of the right medial veptr-ii device had broken.The broken extension piece was explanted and replaced with an identical device during a revision procedure, which was performed on (b)(6) 2016.All other components of the right medial veptr-ii device remained intact and implanted.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: distraction lock (part: 497.125, lot: unknown, quantity: 1) and proximal sleeve (part: 04.641.103, lot: unknown, quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; 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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: the following complaint device was received by customer quality (cq): one ti distal extension size 13/220mm radius (part number: 04.641.123, lot number: 7508190, mfg date: 14nov2013) the part was received with the following complaint description: ¿a vertical expandable prosthetic titanium rib (veptr) ii 220mm distal rib extension broke at the rod/sleeve junction.As the patient bent over while weight bearing, he experienced a popping sensation and pain.Emergency room (er) x-rays confirmed that the distal rib extension of the right medial veptr ii device had broken¿.Upon visual inspection the complaint condition is confirmed; as there is a transverse fracture, the fracture occurred approximately 8.10mm slightly above the most proximal hole of the implant.Additionally, the distal end of the device appears to have been cut and contoured most likely during the original surgery to accommodate for the patient¿s anatomy.The complaint condition is confirmed; the balance of the device is in fair condition; minor wear and tear consistent with an implanted device.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.A visual inspection, drawing review, design history review, complaint history review, and risk assessment review were performed as part of this investigation.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: TI DISTAL EXTENSION SIZE 13/220MM 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: 5706897
• MDR Text Key: 46825573
• Report Number: 2530088-2016-10153
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142587
• 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,Followup
• Report Date: 05/25/2016

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: 04.641.123
• Device Lot Number: 7508190
• Other Device ID Number: (01)10705034750583(10)7508190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/23/2016; 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90