MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW ROD,FIXATION,INTRAMEDULLARY

Model Number 03.037.010

Device Problem Mechanical Jam (2983)

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

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was performed for part no. : 03. 037. 010, lot no. : 9872028, manufacturing location: (b)(4), release to warehouse date: 27. Apr. 2016: no non-conformance reports (ncrs) 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. A product investigation was performed. One percutaneous radiolucent insertion handle (03. 037. 112, 9609762) was returned, but had no alleged complaint, and did not exhibit damage which could have contributed to the complaint conditions. No unknown locking screws were returned. The returned parts are included in the trochanteric fixation nail- advanced (tfn-a) system and used for intramedullary fixation of proximal femoral fractures. The returned cannulated connecting screw (03. 037. 010, 9872028) was received with superficial marks near its threading and minor deformations which could have contributed to the complaint condition. Although there was no damage significant enough to make the screw unusable, as a conservative measure the minor damage which was noticed will be used to confirm the complaint condition, and made its replication inapplicable. The returned cannulated connecting screw (03. 037. 010, 9872028) was manufactured on 27apr16 and relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended. Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition. The material, material properties, and hardness of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material/hardness testing is not required. During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition. Based on the available information it is not possible to determine a definitive root cause for the complaint condition. The relevant diameter of the returned screw was measured and found to be within specification. The returned screw was received in decent condition, but it did exhibit minor superficial marks near its threading, and minor deformations which could have contributed to the complaint condition. If the screw was not aligned properly during insertion into a nail, it could have caused the corresponding threads to cross thread, which could 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.

Manufacturer Narrative

Device is an instrument and is not implanted / explanted. 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 an original surgery to treat a right femur fracture using trochanteric nail fixation- advanced (tfn-a) was performed on (b)(6) 2017. During the surgery, the surgeon was using a 8. 0 mm hexagonal spherical head screwdriver with a t-handle to loosen the connecting screw in order to disassemble the tfna percutaneous handle from an implanted tfna nail. The spherical head screwdriver did not get a strong grasp of the connecting screw and as it was turned counter clock wise, there was a squealing/screeching and multiple pop sounds produced as the connecting screw threads were rubbing against the nail. The surgeon decided to use a ratchet from a different set and was able to successfully remove the connecting screw which caused a 5-minute surgical delay. Also during the same procedure, as the surgeon was inserting an interlocking screw using a t25 hexagonal stardrive interlocking screwdriver, the tip of the screwdriver disengaged from the screw head multiple times. Surgeon proceeded to successfully complete insertion of the interlocking screw using slight pressure. It was noted at the back table that the tip of the t25 hexagonal stardrive interlocking screwdriver was distorted. The patient was reported to be in stable condition. Concomitant devices reported: percutaneous radiolucent insertion handle (part# 03. 037. 112, lot# 9609762, quantity 1); 10 mm/ 130 degree titanium trochanteric nail fixation- advanced (tfn-a) 360 mm/ right ¿ sterile (part# 04. 037. 056s, lot# h394436, quantity 1). This report is for one (1) cannulated connecting screw. (b)(4).

• Brand Name: CANNULATED CONNECTING SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7100777
• MDR Text Key: 255155182
• Report Number: 2939274-2017-50190
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070265
• UDI-Public: (01)10886982070265(10)9872028
• 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

• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 03.037.010
• Device Catalogue Number: 03.037.010
• Device Lot Number: 9872028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown