MAUDE Adverse Event Report: SYNTHES BRANDYWINE BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

Catalog Number	357.369
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.A review of the device history records has been requested.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 or Problem Description
It was reported that during a trochanteric fixation nail (tfn) procedure on (b)(6) 2017, the blade guide sleeve was sticking in the 130 degree aiming arm, making it difficult to disengage the blade guide sleeve from the aiming arm.Surgeon had to unscrew the aiming arm to pull the blade guide sleeve out.Procedure was completed successfully with no delay.This report is for one (1) blade guide sleeve.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed on part #357.369, lot #4436175: release to warehouse date: 12-nov-2002, expiration date: n/a, supplier: barber nichols: no non conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A product development investigation was performed.The following two (2) devices were received with the complaint category of ¿device interaction: does not fit with other parts.¿ -one (1) 130 degree aiming arm for trochanteric fixation nails (part 357.366 / lot 4496500), -one (1) blade guide sleeve for trochanteric fixation nails (part 357.369 / lot 4436175).A device history record (dhr) review, device inspection, functional test, and drawing review were performed as part of this investigation.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.The guide sleeve and aiming are were received with wear consistent with significant use and with their age of approximately 14.5 years.The complaint condition is unconfirmed as the devices were found to function as intended.No new malfunctions were observed during the course of this investigation.The returned instruments are components of the titanium trochanteric fixation nail (tfn) system intended for the intramedullary fixation of proximal femur fractures.The devices are specifically for the insertion of the head element into the nail.Information is provided per relevant technique guides.The guide sleeve and aiming are were received with wear consistent with significant use and with their age of approximately 14.5 years.The surface of each device shows small nicks and wear.The aiming arm also shows two scrapes and a dent on the ¿d¿ shaped hole.The devices were able to be fully assembled and disassembled with no noted issues during functional testing with an in house buttress/compression nut (part number 357.371 / lot number 5013306) and partial assembly without the buttress/compression nut.Thus, as no functional issue was identified, the complaint condition for these devices is unconfirmed and could not be replicated.Relevant drawings were reviewed.The guide sleeve was inspected and the width across the flat was found to be within the specification.The threaded diameter was determined to be under the specification due to post manufacturing wear.This was determined to have not impacted the binding of the two devices.The aiming arm was also inspected at the ¿d¿ shaped hole (outside noted damage) which interacts with the guide sleeve.It was found to be within the specifications of manufacture relevant revision.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.A definitive root cause could not be determined as the condition could not be replicated.There is no evidence of a manufacturing issue and no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6505354
• Report Number: 2530088-2017-10093
• Device Sequence Number: 11025241
• Product Code: FZX
• UDI-Device Identifier: 10886982196033
• UDI-Public: (01)10886982196033(10)4436175
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 357.369
• Device Lot Number: 4436175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR