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

Catalog Number 357.371

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Device history record review for part 357.371, lot4436455: release to warehouse date: november 05, 2002.Manufactured at (b)(4) facility.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.A product investigation was completed: the complaint condition for the 357.371 lot number 4436455 buttress/compression nut was likely caused by over twelve years of consistent use and wear; however, this complaint is not likely a result of any design related deficiency.Per the technique guide, the 357.371 buttress/compression nut is an instrument routinely used in the titanium trochanteric fixation nail system.The device was returned and reported to be disengaging from the aiming arm.This condition is confirmed; when tested with a 357.366 lot number 4567005 aiming arm test sample the nut will disengage with minimal force applied to the device.It is likely that over twelve years of consistent use and wear has led to this complaint condition.The device was manufactured in november 2002 and is over twelve years old.The balance of the returned device is in worn condition with numerous markings on both faces and along the knurled edge.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.The complaint condition for this device can be replicated.The risk assessment adequately addresses the complaint event.No non-conformance reports germane to the complaint condition were generated during the production of this device.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 a trochanteric fixation nail (tfn) buttress compression nut was disengaging from the aiming arm during a tfn procedure.It was reported that the compression nut appeared worn and there is no allegation against the aiming arm or associated guide sleeve.A five (5) minute surgical delay was reported and the surgery was completed successfully with a back-up set of devices.This is report 1 of 1 for (b)(4).

• 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: 5188734
• MDR Text Key: 29869806
• Report Number: 2530088-2015-10680
• 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: Health Professional
• Type of Report: Initial
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• 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: 4436455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2002
• 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: 85 YR
• Patient Weight: 85