MAUDE Adverse Event Report: SYNTHES SALZBURG 2.0MM TI ELASTIC NAIL 440MM; PIN,FIXATION,SMOOTH

Catalog Number 475.920

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(6).Device is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review was conducted.The report indicates that the: 475.920 / 5935963, manufacturing location: (b)(4), manufacturing date: 04 september 2015.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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 during surgery the cone was bending.No information about patient condition received.This complaint involves 1 part.This report is 1 of 1 for com-(b)(4).

• Brand Name: 2.0MM TI ELASTIC NAIL 440MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5794272
• MDR Text Key: 49536509
• Report Number: 3009417901-2016-10023
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971783
• 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
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 475.920
• Device Lot Number: 5935963
• Other Device ID Number: (01)07611819093027(10)5935963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1