MAUDE Adverse Event Report: SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.026

Device Problems Fitting Problem (2183); Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient id, date of birth and weight are not available for reporting.Date of event is unknown.Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 03.037.026, lot# 9375197.Manufacturing location: (b)(4), manufacturing date: feb 16, 2015.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 underwent surgery for a right hip fracture on (b)(6) 2017.It was noted that prior to the surgery, before the patient entered the operating room, the staff had difficulty threading the helical blade inserter and helical blade coupling screw together.It was reported that the threads on one of the devices were damaged but it is unclear which device had the problem.The devices were able to be attached and were used in the surgery without any problems.The surgery was completed successfully without any delays and the patient was reported as stable.This report is for one (1) helical blade/screw coupling screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: a product development investigation was performed.One (1) helical blade inserter (part number 03.037.024 / lot number t112026) and one (1) helical blade/screw coupling screw (part number 03.037.026 / lot number 9375197) were received with the complaint category of ¿device interaction: does not fit with other parts.The complaint condition is confirmed for the coupling screw as the device was received with visible deformation of the proximal threads.However, the complaint condition for the inserter is unconfirmed as visual inspection from the proximal end of the cannulation noted that the inner proximal threads appear worn but intact and functional.The inserter was also noted to be missing the epoxy color coding.The returned devices are part of the trochanteric fixation nail advanced (tfna) system.The blade/screw coupling screw is used through the cannulation of the helical blade inserter to retain the helical blade during insertion.They also each have proximal threads that allow the coupling screw to be retained in the inserter, preventing accidental disassembly [tfna technique guide].The helical blade inserter was received with the blue handle disassembled from the device.The handle can be reassembled as intended.The surface of the device shows wear with impact marks on the distal surface of the ledge directly below the blue handle.Visual inspection from the proximal end of the cannulation noted that the inner proximal threads appear worn but intact and functional.It was also observed that the epoxy color-coding had fallen off the inserter.The coupling screw was received with visible deformation of the proximal threads.These threads show flattening and scraping.Impact marts consistent with use were observed on the proximal surface of the device.However, impact marks inconsistent with recommended use were observed on the underside of the proximal end of the device as well.The returned devices were functionally tested and could be assembled but more resistance was encountered due to the deformation of the proximal threads on the coupling screw.Thus, the complaint condition is confirmed, consistent with the reported condition, and can be replicated.Based on the date of manufactured the relevant drawings were reviewed.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.No definitive root cause was able to be determined as circumstances surrounding the event are unknown.The observed damage of the threads on the coupling screw is consistent with applied force to the coupling screw while the proximal threads were still engaged or adjacent to the threads of the inserter.These threads are intended to prevent accidental disassembly during use.They would not be engaged during recommended use and the coupling screw is to be unthreaded for disassembly.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: HELICAL BLADE/SCREW COUPLING SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6267681
• MDR Text Key: 65457620
• Report Number: 9612488-2017-10034
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070425
• UDI-Public: (01)10886982070425(10)9375197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2017

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
• Device Operator: Physician
• Device Catalogue Number: 03.037.026
• Device Lot Number: 9375197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2017
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• 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: 25 YR