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

Device Problems Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The ¿ 510k: this report is for an unknown proximal femoral nail antirotation (pfna) blade /unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 follows: it was reported that a proximal femoral nail antirotation (pfna) blade could not be removed twice, during a planned hardware removal.This complaint captures the second removal trial in the first hospital providing care.No patient harm occurred and the surgery was not prolonged.Concomitant devices: pfna nail (quantity: 1).This report is for an unknown proximal femoral nail antirotation (pfna) blade.This is report 1 of 1 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.

Manufacturer Narrative

An investigation summary: the investigation of the complaint articles has shown that: our legal department performed directly a statement to the expert for a medical association.It was reported: the patient went to the operating room for a planned removal of hardware.The surgeon could not remove the pfna blade so left all hardware in place.The surgeon attempted to remove the pfna blade in second surgery but was unsuccessful again.- without x-rays we cannot determine, was the pfna blade in the position locked or unlocked.If the blade unlocked it could be an issue by the implant removal.- if not possible to remove the pfna blade, we had special removal - instruments and the existent guideline of removal - surgery.Should further information become available this determination will be reviewed accordingly.Dhr review could not be conducted.No parts, article- lot number received for investigation.Without investigation it cannot be defined if a corrective action is necessary.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.

• 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: 6446835
• MDR Text Key: 71288190
• Report Number: 2520274-2017-11121
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• 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: 05/18/2017
• 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