MAUDE Adverse Event Report: SYNTHES MONUMENT TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER; CERCLAGE, FIXATION

Catalog Number 498.806S

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

Patient Problem Sedation (2368)

Event Date 11/11/2014

Event Type  Injury  

Event Description

It was reported the trochanteric reattachment failed to hold during surgery (cable set was used).A cerclage wire was used as an alternate.The patient status outcome is unknown.There was a less than desirable treatment outcome.The procedure was successfully completed, the event resulted in a greater than a 30 minute delay.This is report 5 of 6 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The device history review reported: (b)(4).There was no material review reports, nonconformance reports, or complaint related issues with this lot.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.

• Brand Name: TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4316768
• MDR Text Key: 20978154
• Report Number: 1719045-2014-10670
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK001709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 498.806S
• Device Lot Number: P137282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 78