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

Catalog Number 357.371

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information not provided by reporter.Event date: unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a valid lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Mfr date: unknown.Dhr review ¿ no dhrs could be located for part#/lot# combination part #357.371, lot # 5013304.Therefore, a dhr review could not be performed.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 patient had surgery the week of (b)(6) 2015 due to a hip fracture.The trochanteric fixation nail system was utilized.During surgery, the blade guide sleeve for trochanteric fixation nails (threaded trocar) (357.369; lot #: 4964345) and the buttress/compression nut (357.371; lot #: 5013304) became cross threaded and bound up.The surgeon was unable to advance the nut on the trocar.The surgeon was unable to advance the nut on the trocar and therefore, the parts were unable to be separated after the surgery.This delayed the procedure by approximately five (5) to ten (10) minutes and the surgeon successfully finished the procedure without any surgical/medical intervention.The surgery was successfully completed and the patient status/outcome is unknown.No further surgery or special follow up is expected to be required.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Product investigation summary: one buttress/compression nut (part 357.371 / lot 5013309) and one blade guide sleeve (part 357.369 / lot 4964345) were received with the complaint categories: ¿device interaction: sticks/jams/stuck¿ and ¿does not/will not function: cross threaded,¿ respectively.The complaint condition was able to be replicated as the buttress/compression nut was unable to be fully unthreaded from the blade guide sleeve due to thread damage on the sleeve approximately 1/3 of the way down from the proximal end of the instrument.The buttress/compression nut and blade guide sleeve 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 technique guides.The returned devices were received with significant surface scratches, wear, and dents.There is deformation and scratches on the knurled surface of the buttress compression nut.Additionally, the distal edge of the buttress compression nut is rolled over and there scratches and dents on the threads of the blade guide sleeve.When tested functionally, the buttress/compression nut could not be advanced over the entire threaded length of the blade guide sleeve as it would bind approximately 1/3 of the way down from the proximal end of the instrument.Thus, the complaint condition is confirmed, consistent with the reported condition and was able to be replicated.A review of the current design drawing/manufactured revision for the buttress/compression nut and the blade guide sleeve was performed.The design history was found to not impact the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.Since the specific circumstances at the time of the damage are unknown the root cause cannot be definitively determined.However, it is most probable that accumulated wear from rough handling and excessive force during surgery and/or sterile processing resulted in this condition.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 history record review: manufacturing location: (b)(4), manufacturing date: august 12, 2005.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 the 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.

• 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: 5091642
• MDR Text Key: 26480889
• Report Number: 2530088-2015-10591
• 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: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• 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: 5013309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2005
• 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