MAUDE Adverse Event Report: SYNTHES USA; ROD,FIXATION,INTRAMEDULLARY

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

This report is for one (1) unknown helical blade.Part and lot numbers are unknown.Without the specific part and lot numbers, te udi is not available.Device is implanted; as such explant date is not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.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.

Event Description

It was reported the helical blade insertion handle and the connecting screw became extremely loose when inserting the helical blade during a trochanteric fixation nail (tfn) case on (b)(6) 2017, no matter how much it was tightened.The surgical tech took apart the insertion handle (via how it is to be disassembled for cleaning purposes) and reassemble, to make sure it was put together properly.The helical blade was inserted a second time, with the handle and connecting screw continuously being loose.When the surgeon started malletting, the helical blade was in line to impact the nail, but did not go through the assigned cut-out.The flutes of the helical blade were about to pass through the nail, we looked at the x-ray (not available), which showed the most superior portion of the blade, if inserted any further, was going to make contact with the proximal portion of the nail.It was at this time the helical blade was removed.Another tfn locking set was used and attached to the same helical blade and to a different inserter and connecting screw, to which the helical blade was advanced with no further issues.There was a 25-minute surgical delay.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: mallet hammer (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) unknown helical blade.This is report 2 of 2 for complaint (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6718036
• MDR Text Key: 80305067
• Report Number: 2520274-2017-11938
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• 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 Age: 58 YR
• Patient Weight: 70