MAUDE Adverse Event Report: SYNTHES USA 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM; APPLIANCE, FIXATION, NAIL

Catalog Number 281.102

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

Patient Problems Skin Irritation (2076); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional product code: jdo.(b)(4).Original implant date was sometime in (b)(6) 2010 in (b)(6).Device is not expected to be returned for manufacturer review/investigation.The patient felt that the device was rubbing and felt she may have an allergic reaction to the device.Should further information become available this determination will be reviewed accordingly.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

It was reported that a hardware removal was done for implants that were originally implanted in (b)(6) 2010.The patient states that the implants were rubbing, but now she is wondering if she had an allergic reaction to the material.The physician stated that the patient did not have a lot of padding and is a small person so it could be problematic.This report is 1 of 5 for (b)(4).

• Brand Name: 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 6455721
• MDR Text Key: 71577009
• Report Number: 2520274-2017-11171
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 281.102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2017
• 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