MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 456.322S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Date of event is unknown.Additional classification code: hwc.Not applicable since a back-up implant was used to complete the procedure.A device history record review was performed for the subject device: manufacturing location: (b)(4).Manufacturing date: 26-oct-2017.Expiration date: 30-sep-2026.Part #: 456.322s, lot#: h485446 (sterile) - 12mm/130 deg ti cann troch fixation nail 170mm - sterile.Quantity 6.Component parts reviewed: part 456.314.3 - lock driver tfn bp 55 lot: h422974-(1), h396622-(5), part 456.315.2 - 130 lock prong tfn bp 58 lot: h422714-(2), h419000-(4).Raw material part no: 21069 bp 80, 9922158 - raw material for titanium received from supplier (b)(4).Certificate of test for titanium received from ati meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for in-process/inspect dimensional/final (b)(4) rev: j met inspection acceptance criteria.No 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.Ethicon (abq), ¿sterility documentation was reviewed and determined to be conforming.¿ no 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 development investigation was performed for the subject device: the returned trochanteric fixation nail (tfn) (456.322s, h485446) is part of the ti trochanteric fixation nail system (dsus/trm/1016/1139 and dsus/trm/1115/0765) for the intramedullary fixation of proximal femur fractures.The returned nail was received in decent condition, and it was not possible to confirm that the nail was received disassembled upon receipt.Upon further inspection it was noticed that the lock drive threading was damaged, therefore the complaint condition of stripped/worn was confirmed and further replication is inapplicable.The returned nail (456.322s, h485446) was manufactured on 26oct2017 and drawings 456_314, 456_314_1, 456_314_2, and 456_314_3 were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).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 properties 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 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 investigation findings, it has been determined that no corrective and/or preventative action is proposed.Measurement of the lock drive threading was not possible due to post-market damage.Dimensional check (ca215p).Drawing: 456_314_2.Feature: lock proximal diameter specification= ø10.60 to 10.65mm.Measured: ø10.63 (conforming).Feature: locking tab thickness specification= 0.7 to 0.8mm.Measured: 0.77mm (conforming).Based on the available information it is not possible to determine a definitive root cause for the complaint condition.The locking mechanism is intended to be advanced within nails to control the rotation of helical blades.It was reported that during the procedure the user experienced several unsuccessful attempts to mate the connecting screw with the tfn nail.It is possible that the threading of the lock drive became damaged during the struggles experienced while attempting to mate the subject connecting screw with the nail.It was also stated that the locking mechanism was seated higher up than expected.If the positioning of the locking mechanism was manipulated prior to surgery or due to struggles faced during surgery, it 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.

Event Description

It was reported that a trochanteric fixation nail (tfn) nail malfunctioned during a patient procedure on (b)(6) 2018 that was performed to treat an intertrochanteric fracture.During the procedure after alignment of the tfn nail with the insertion handle, the internal locking mechanism in the tfn nail was seated too high in the device and would not advance.The threads on the tfn nail became stripped after the connecting screw was passed through the insertion handle to mate with the tfn nail.Several unsuccessful attempts were made to mate the connecting screw with the tfn nail which resulted in a 5-7 minute surgical delay.There was a similar back-up implant of the same size that was used to complete the procedure.No harm was reported to the patient.Patient outcome was reported fine.No malfunctions were against the insertion handle or coupling screw.Concomitant devices reported: insertion handle (unknown part and lot numbers, quantity: 1), connecting screw (unknown part and lot numbers, quantity: 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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

Concomitant devices updated.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 trochanteric fixation nail (tfn) nail malfunctioned during a patient procedure on (b)(6) 2018 that was performed to treat an intertrochanteric fracture.During the procedure after alignment of the tfn nail with the insertion handle, the internal locking mechanism in the tfn nail was seated too high in the device and would not advance.The threads on the tfn nail became stripped after the connecting screw was passed through the insertion handle to mate with the tfn nail.Several unsuccessful attempts were made to mate the connecting screw with the tfn nail which resulted in a 5-7 minute surgical delay.There was a similar back-up implant of the same size that was used to complete the procedure.No harm was reported to the patient.Patient outcome was reported fine.No malfunctions were against the insertion handle or coupling screw.Concomitant devices reported: insertion handle (part number unknown, lot number unknown, quantity 1), cannulated connecting screw for trochanteric fixation nails (part 357.397, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7462356
• MDR Text Key: 107163213
• Report Number: 2939274-2018-51924
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982226969
• UDI-Public: (01)10886982226969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2018

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: Health Professional
• Device Model Number: 456.322S
• Device Catalogue Number: 456.322S
• Device Lot Number: H485446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 04/26/2018; 04/26/2018
• Supplement Dates FDA Received: 04/26/2018; 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1