MAUDE Adverse Event Report: SYNTHES USA EXPERT A2FN NAIL Ø11 R CANN L380 TAN LIG; NAIL, FIXATION,BONE

Catalog Number 04.009.456S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Event date: unknown when non-union or breakage started.This report is for unknown expert a2fn nail ø11 r cann l380 tan lig/unknown lot number.Device is not distributed in the united states, but is similar to device marketed in the usa.(b)(4).Device was implanted 18 months ago.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an event in (b)(6) as follows it was reported that this was the patients second revision.Nail broke through distal recon screw hole after 18 months since implantation.Surgeon described it as a hypertrophic non-union but did not think the implant was at fault given it was implanted 18 months ago.Nail and all locking screws were removed and the fracture was revised with a 13 x 400mm right sided a2fn nail.The surgeon did not require investigation into the nail or testing of the material.The surgeon was satisfied with the fixation achieved following revision operation.This complaint involves one part.This report is 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.

• Brand Name: EXPERT A2FN NAIL Ø11 R CANN L380 TAN LIG
• Type of Device: NAIL, FIXATION,BONE
• 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: 6090463
• MDR Text Key: 59553547
• Report Number: 2520274-2016-15331
• Device Sequence Number: 1
• Product Code: JDS
• 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,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.009.456S
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• 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