MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 340MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.054S

Device Problem Fitting Problem (2183)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 06/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was not implanted or explanted during the reported surgical procedure.(b)(4).Product investigation summary: the following devices were received with the complaint category of ¿device interaction: does not fit with other parts.¿ one (1) cannulated connecting screw (part 03.037.010 / lot 9167359); one (1) complete radiolucent insertion handle (part 03.037.012 / lot 9374514); one (1) 10mm/130 degree titanium cannulated tfna nail (part 04.037.054s / lot 7829362); one (1) tfna helical blade (part 04.038.285s / lot 9888204) was also received with a classification as concomitant.No additional investigation will be performed on this device.The complaint condition is unconfirmed as functional testing of the returned insertion handle, nail, and connecting screw found that the devices could be securely assembled and disassembled as intended.No functional issues were observed throughout testing.The returned devices are part of the trochanteric fixation nail advanced (tfna) system.The cannulated connecting screw secures the insertion handle to all the tfna nails by threading into the threads on the proximal end of the nail through the use of the ball hex screwdriver.The returned implants (nail and helical blade) were received intact with surface wear patterns consistent with implant and explant.The lock prong of the nail shows bending that was likely a result of the blade removal.Functional testing of the returned insertion handle, nail, and connecting screw was performed by assembling and disassembling the devices (3) separate times.The devices were able to be securely assembled and disassembled as intended.No functional issues were observed throughout testing.Thus, as no functional issue was identified, the complaint condition is unconfirmed and could not be replicated.A review of the current design drawings was performed.Further investigation had previously been completed for the tfna connecting screw binding with the tfna insertion handles causing disassembly issues.Per the investigation, the issue could be replicated with a standardized test setup.Soft tissue pressure was simulated on a vertical tension/compression testing machine.Friction between the instrument interfaces was detected.The friction led to difficulties in disassembly.No damage/galling of the instruments or implants was detected during/after the test.It was possible to disassemble the instruments from the implants once the soft tissue pressure was neutralized by pulling the aiming arm towards lateral.Device history record review: manufacturing location: (b)(4) ¿ manufacturing date: november 3, 2014 ¿ expiry date: september 30, 2024.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The sterility documentation was reviewed and determined to be conforming.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 originally reported that a patient underwent treatment with a trochanteric fixation nail - advanced (tfn-a) system on (b)(6) 2016 for a right subtrochanteric femur fracture during which the connecting screw malfunctioned.The nail and helical blade were inserted into the femoral head.The surgeon engaged the set screw with the helical blade.The surgeon was not able to disconnect the connecting screw held by the insertion handle from the nail.The helical blade and nail were backed out of the patient.On the back table, a flat wrench was used around the t-handle ball hex screwdriver to turn the connecting screw counterclockwise to disengage it from the nail.The surgeon was unable to do this on his own; it required the surgical technician applying counter torque to the insertion handle while the surgeon used the t-handle ball hex screwdriver with a flat wrench to disengage the connecting screw.It required each of them to exert an incredible amount of effort and force.The surgeon was concerned with the current nail and noticed scoring on the helical blade, so he requested new implants.The femoral canal was reamed to accommodate a larger nail.There was only one set of tfn-a nails at the hospital so a larger diameter nail with the same length and neck angle was used.The patient was implanted with a new nail and a new helical blade.A new connecting screw and original insertion handle were used for insertion of the implants.Distal screws were subsequently implanted.There was an estimated 30-45 minute surgical delay.The procedure was successfully completed and the patient's postoperative outcome was reportedly "good".Updated information: due to an identified issue with the disassembly, the nail and the insertion handle have been added as complainant devices on this complaint.Concomitant device(s) reported: t-handle ball hex screwdriver (part/lot: unknown / quantity: 1) and tnfa helical blade (part: 04.038.285s / lot: 9888204 / quantity: 1).This report is 3 of 3 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 340MM/RIGHT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5853847
• MDR Text Key: 51384312
• Report Number: 1719045-2016-10592
• Device Sequence Number: 1
• Product Code: HSB
• 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
• Report Date: 06/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.054S
• Device Lot Number: 7829362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 04.038.285S: TFNA HELICAL BLADE
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 61