MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient id and date of birth/age was not provided for reporting.The thread of blade was damaged during the implant procedure on an unknown date in (b)(6) 2016.Patient serious injury due to additional intervention occurred on (b)(6) 2017.This report is for one (1) unknown pfna blade (head element).Part#, lot# and udi # is not available.Date of implant and therapy date is an unknown date in (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown pfna blade (head element).Pma/510(k) number is not available.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 follows: it was reported that on an unknown date in (b)(6) 2016, patient was implanted with the nail and the blade.During the procedure, the surgeon damaged the thread of the blade.On (b)(6) 2017, a surgery was performed to extract the implants.They used the normal extraction set but they could not remove the blade as the thread was damaged, the surgery was prolonged for approximately 60 minutes.They had no special instrument to extract the blade from the nail and therefore, closed the surgery without extracting the implants.A special extraction set was sent with tongs to grip that on the blade.During the second surgery on (b)(6) 2017 they could successfully extract the blade and the nail.Patient outcome was not reported.Concomitant reported parts: extraction screw (part# 03.010.411, lot# unknown, quantity 1).This report is for one (1) unknown pfna blade (head element).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Investigation summary indicates that the: complained issue could not be replicated and/or confirmed based on the available information.No pictures and/or x-ray¿s were provided and no material was returned for investigation.Dhr reviews could not be conducted due the insufficient information¿s.No further investigation possible as there were no material available, products were not returned to our location, without an investigation, it cannot be defined if a corrective action is necessary.The root cause could not be defined due the missing material.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: APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• 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: 7038906
• MDR Text Key: 92288253
• Report Number: 2520274-2017-12655
• Device Sequence Number: 1
• Product Code: KTW
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• 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: 130