MAUDE Adverse Event Report: SYNTHES GMBH IMPACTOR F/PFNA BLADE

Catalog Number 356.823

Device Problem Metal Shedding Debris (1804)

Patient Problem Eye Injury (1845)

Event Type  Injury  

Event Description

Device report from synthes (b)(6) reports an event in (b)(6) as follows: it was reported on (b)(6); that on unknown date during the explantation of the proximal femoral nail antirotation blade with impactor, the eye of the employee was penetrated by a spalling metal from the instrument.The operation was performed by a colleague; the patient was not harmed.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unable to determine if patient is for surgical patient or injured employee.Device is an instrument.Device is not distributed in the united states, but is similar to device marketed in the usa.Investigation could not be completed and no conclusion could be drawn as no device was returned.A review of device history records was performed and no complaint related issues were found during manufacturing that would contribute to this complaint.Placeholder.

• Brand Name: IMPACTOR F/PFNA BLADE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: gabriel szasz ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3558904
• MDR Text Key: 4073560
• Report Number: 8030965-2013-05699
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 356.823
• Device Lot Number: 2170259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR