MAUDE Adverse Event Report: SYNTHES USA PFNA Ø12 LONG R 130° L380 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.268S

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

Patient Problems Impaired Healing (2378); No Code Available (3191)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

Patient¿s age is reported approximately in 70s.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Device was reportedly discarded.(b)(6).(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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

Device report from synthes europe reports an event in (b)(6) as follow: it was reported that on (b)(6) 2015, patient underwent initial implant procedure.On (b)(6) 2016, the patient was revised from a pfna nail to lfn or blade plate due to non-union.The implant was not broken and the surgeon believes that the patient experienced a non-union related to "bad" fracture and the patient's poor biology-rheumatoid arthritis.No delay in surgery was reported.Patient outcome was reported well one day after revision procedure.This report is for one (1) pfna nail.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

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.

• Brand Name: PFNA Ø12 LONG R 130° L380 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6125882
• MDR Text Key: 60843177
• Report Number: 2520274-2016-15492
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 04.027.268S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• 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