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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report is for one unknown tfn nail.Part and lot numbers are not available for reporting.Other number¿udi: unknown part number, udi is unavailable.Therapy date: unknown date in 2014.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.Patient code (b)(4) was utilized for revision surgery.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 revision surgery with hardware removal was performed on (b)(6) 2017 due to osteoarthritis.The patient originally underwent the trochanteric fixation nail (tfn) procedure on an unknown date in 2014.The hardware was removed during the (b)(6) 2017 revision surgery and the patient was revised to a total hip replacement.The surgery was completed successfully and patient is reported to be in stable condition.This report is for one unknown tfn nail.This report is 1 of 3 for (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: 6349314
• MDR Text Key: 67993006
• Report Number: 2520274-2017-10566
• 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: Other
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• 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 Outcome(s): Required Intervention
• Patient Weight: 76