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

Catalog Number 357.371

Device Problem Separation Failure (2547)

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

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

No reported patient involvement.Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history record review: manufacturing date: may 19, 2003 - manufacturing site: (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.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.

Event Description

It was reported that a blade guide sleeve for trochanteric fixation nails and a buttress compression nut could not be pulled apart.It appeared that the threads of the guide sleeve were damaged, which prevented threading and passing of the buttress nut.The issue was discovered during sterile processing with no reported patient or procedural involvement.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

A product investigation was completed: the complaint condition for the 357.369 lot number 6320172 blade guide sleeve and 357.371 lot number 4546697 buttress/compression nut was likely caused by numerous years of consistent use and possibly rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design related deficiency.Per the technique guide, the 357.369 blade guide sleeve and 357.371 buttress/compression nut are instruments routinely used in the titanium trochanteric fixation nail system.The devices were returned and reported to not pull apart.This condition is confirmed; the two devices were received in customer quality separately, but upon testing them together the devices became stuck and unable to be detached from one another using a moderate amount of force.It is likely that numerous years of consistent use and possibly rough handling during surgery or sterile processing has led to thread deformation on these devices and ultimately this complaint condition.The 357.369 sleeve was manufactured in april 2010 and is over five years old.The 357.371 nut was manufactured in may 2003 and is over twelve years old.The returned devices are in fairly worn condition consistent with their respective ages.The relevant 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 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.

• 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: 5360632
• MDR Text Key: 36083663
• Report Number: 2530088-2016-10005
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• 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: 4546697
• Other Device ID Number: (01)10886982196057(10)4546697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2003
• 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