MAUDE Adverse Event Report: SYNTHES USA PFNA Ø10 125° L240 TAN; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 472.260S

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a proximal femoral nail antirotation (pfna) blade and nail removal surgery was performed on (b)(6) 2016 due to a collapsed femoral head.A total hip replacement was performed.Patient outcome was reported to be good.Concomitant device reported as: 4.9mm ti locking bolt 36mm (part # 459.360, lot # unknown, quantity 1) this is report 1 of 2 for (b)(4).

• Brand Name: PFNA Ø10 125° L240 TAN
• 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: 6181318
• MDR Text Key: 62601300
• Report Number: 2520274-2016-15694
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 472.260S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• 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
• Treatment: ONE (1) 4.9MM TI LOCKING BOLT 36MM (459.360)
• Patient Outcome(s): Required Intervention