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

Catalog Number 357.371

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

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

Event Date 04/29/2015

Event Type  malfunction  

Event Description

It was reported that the blade guide sleeve/buttress compression nut assembly kept popping off of the aiming arm during a trochanteric fixation nail (tfn) procedure on (b)(6) 2015.The issue reportedly occurred while the surgeon was tightening down toward the lateral cortex.The procedure was successfully completed with a two (2) minute surgical delay.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Additional narrative: patient initials are (b)(6).Patient weight is unknown.Device is an instrument and is not implanted or explanted.(b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Device history review: this lot was manufactured on may 18, 2006 at (b)(4).The device history record was reviewed; no anomalies were reported during the manufacturing process of this lot that can be related to this complaint.Device 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.

Manufacturer Narrative

Product investigation summary: the complaint condition for the buttress/compression nut (part 357.371 / lot 5176490) and the 130 degree aiming arm (part 357.366 / lot 9014558) was likely caused by excessive hammering during surgery; however, this complaint is not a result of any design related deficiency.No product issue was identified in the complaint or noted upon examination of the returned blade guide sleeve (part 357.369 / lot 5056415).The buttress/compression nut, 130 degree aiming arm, and the blade guide sleeve are instruments routinely used in the titanium trochanteric fixation nail system.The buttress/compression nut and the 130 degree aiming arm were returned and reported to have come apart during surgery.This condition is unconfirmed; using a moderate amount of force, the two devices could not be separated from one another without pressing the button which releases the nut.It is likely that excessive hammering during surgery has led to this complaint condition.The nut was manufactured in may 2006 and is nine years old.The balance of the device is in fair condition with some markings along the knurled outer edge.The associated drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned devices does not agree with the complaint description.The complaint condition for this device cannot be replicated.It is likely that excessive hammering during surgery has led to this complaint condition.Device 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 BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4784509
• MDR Text Key: 5877912
• Report Number: 2530088-2015-10409
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• 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: 5176490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2006
• 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: 90 YR