MAUDE Adverse Event Report: SYNTHES MONUMENT BUTTRESS/COMPRESSION NUT FOR 357.369; TRACTION, APPARATUS, NON-POWERED

Catalog Number 357.371

Device Problem Failure to Align (2522)

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

Event Date 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part number: 357.371, lot number: 7559684: release to warehouse date: 27february2014.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.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 during a trochanteric fixation nail (tfn) insertion, the helical blade would not pass through the nail.It was then noted that the aiming arm was loose.The helical blade was able to be passed through the nail after the aiming arm was tightened and the guide wire was removed.There was a fifteen (15) minute surgical delay.The procedure was completed successfully; the patient status was reported as fine.No additional information was available.This is report 4 of 8 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the insertion handle, aiming arm, blade guide sleeve, helical blade inserter, helical blade coupling screw, and buttress compression nut were returned.The complaint description stated that initially the helical blade would not pass through the nail but could be successfully inserted once the loose aiming arm was tightened.There was a 15 minute surgical delay.From the description, the ultimate root cause of the helical blade/nail misalignment is the loose connection between the aiming arm and a connecting instrument.The complaint conditions could not be fully replicated but, upon evaluation of the returned items, the aiming arm construct remained securely attached even after manual manipulation of the device.Root cause of the complained misalignment is a loose connection of the aiming arm as a result of human error.As identified by the reporter, the alignment was corrected by tightening the aiming arm.No design issues were noted during the evaluation.Device was used for treatment, not diagnosis if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: TRACTION, APPARATUS, NON-POWERED
• 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: 5247110
• MDR Text Key: 32053352
• Report Number: 1719045-2015-10768
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

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: 357.371
• Device Lot Number: 7559684
• Other Device ID Number: (01)10886982196057(10)7559684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 70