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Catalog Number 03.037.012
Device Problem Fitting Problem (2183)
Patient Problems Sedation (2368); No Code Available (3191)
Event Date 06/11/2016
Event Type  Injury  
Manufacturer Narrative
Device is an instrument and is not implanted or explanted. (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. Upon visual and functional inspection of the concomitant helical blade, and without an alleged complaint condition, there is no evidence that this device contributed to the complaint condition. Therefore, 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 three (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 or galling of the instruments or implants was detected during or 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: april 9, 2015. No anomalies were detected during device history record review. 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. 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 2 of 3 for (b)(4).
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Manufacturer (Section D)
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer (Section G)
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
MDR Report Key5853800
MDR Text Key51383525
Report Number3003875359-2016-10435
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.012
Device Lot Number9374514
Other Device ID Number(01)10886982070289(10)9374514
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/08/2016 Patient Sequence Number: 1