MAUDE Adverse Event Report: SYNTHES USA 8MM TI CURVED RADIAL STEM 44MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 04.402.028S

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 01/20/2015

Event Type  Injury  

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 4 of 5 for (b)(4).

Manufacturer Narrative

It has not been reported that the device has been 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

(b)(6).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 TI CURVED RADIAL STEM 44MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4475772
• MDR Text Key: 5567311
• Report Number: 2520274-2015-10698
• 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
• 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: 04.402.028S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention