MAUDE Adverse Event Report: SYNTHES MONUMENT 8MM OFFSET BROACH/CURVED TIP FOR RADIAL HEAD PROSTHESIS; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 03.402.733

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 01/20/2015

Event Type  Injury  

Manufacturer Narrative

Product investigation evaluation: the complaint condition for part number 03.402.733 (with lot number 6905068) offset 8.0mm broach, curved tip was likely caused by improper orientation of the forearm or using too large a broach; however, this complaint is not a result of any design related deficiency.The offset 8.0mm broach, curved tip is an instrument routinely used in the radial head prosthesis system.The returned device was received in very good condition with almost no visible wear.The device was manufactured in december 2012 and is over two years old.The device was returned and reported to not be able to broach to the proper depth causing the implant to not seat entirely in the canal.This condition is unconfirmed due to the inability to test this condition; however, the device is in good condition and it is likely that the complaint condition was caused by either the surgeon using too large a broach or that the forearm was not in the proper position during surgery.Drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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 during a procedure on (b)(6) 2015 the surgeon experienced difficulty while broaching the radial canal with the 7mm and 8mm broach.During broaching with the 8mm broach it was noted that the last 5mm of useable broach length would not advance all the way which resulted in the 8mm trial stem not fully seating into the radial canal.This in turn resulted in the implant not properly seating in the radial canal and remaining prominent by 3-5mm.This event resulted in a thirty minute surgical delay and additional x-rays being performed.The procedure was completed successfully.This is report 1 of 5 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Used to capture unanticipated intra-operative x-rays.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Patient initials are (b)(6).Subject device has been received; no conclusion could be drawn as the product is entering the complaint system.Device history review: lot 6905068 - (b)(4) manufactured the 8mm offset broach/curved tip for radial head prosthesis, p/n 03.402.733 and lot 6905068.Initially, the part conformed to the supplier¿s certificate of conformance, dated november 29, 2012, and was inspected and conformed to the synthes final inspection sheet.The parts were released to the warehouse on december 4, 2012.There were no material record reports, non-conformance reports, or complaint related issues with this lot.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

Update: it was reported via an update that no difficulty occurred while broaching with the 7mm broach; only with the 8mm.

• Brand Name: 8MM OFFSET BROACH/CURVED TIP FOR RADIAL HEAD PROSTHESIS
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4475749
• MDR Text Key: 12977962
• Report Number: 2520274-2015-10694
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.402.733
• Device Lot Number: 6905068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention