MAUDE Adverse Event Report: SYNTHES MONUMENT TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/LONG-STERILE

Catalog Number 498.807S

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  Injury  

Event Description

Complaint handling unit received a user facility report for medwatch (b)(4) via standard mail on (b)(6), 2013, in maude format.That information will not be duplicated.All information herein has been provided by the customer facility 3500a.This report is for 1 ti trochanteric reattachment device w/cables/long-sterile.This is report 3 of 4 for complaint (b)(4).

Manufacturer Narrative

Patient information provided subsequent to facility 3500a report to fda.The investigation could not be completed; no conclusion could be drawn, as the product was not returned.A review of the device history records was performed and no complaint related issues were found.Placeholder.

• Brand Name: TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/LONG-STERILE
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: k myers ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3591334
• MDR Text Key: 4143398
• Report Number: 1719045-2014-00024
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• PMA/PMN Number: K001709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2017
• Device Catalogue Number: 498.807S
• Device Lot Number: P131732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 88