MAUDE Adverse Event Report: SYNTHES HAGENDORF PERCUTANEOUS RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.112

Device Problems Fitting Problem (2183); Mechanical Jam (2983)

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

Event Date 05/29/2016

Event Type  Injury  

Manufacturer Narrative

Patient initials are (b)(6).Device is an instrument and is not implanted or explanted.(b)(4).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: february 17, 2015.No non-conformance reports 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.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 reported that an intertrochanteric hip fracture procedure was performed on (b)(6) 2016 using a trochanteric fixation nail advanced (tfna) system.The surgeon chose an 11mm x 125 degree angle (short) tfna nail for the patient.The surgery was near completion when the distal interlock was placed.The surgeon attempted to remove the carbon fiber percutaneous handle with a ball hex screwdriver when it was discovered that the connecting screw had cold-welded to the nail.As more force was applied to loosen the connecting screw, the screwdriver broke leaving a hexagonal portion/fragment in the connecting screw.At this time, the insertion handle and connecting screw were still attached to the nail with no access for removal as the connecting screw contained the broken tip of the driver.The surgeon decided to reconnect the lag screw inserter and remove the lag screw from the femoral head, which was successful.Then, the distal locking screw and nail were removed.A new nail was opened and inserted with a new instrumentation.The same lag screw and distal interlock screw were re-inserted.At that point, the surgeon felt comfortable with the implants; the surgery was completed successfully.Due to the intra-operative issues and consultation, the procedure was extended by one (1) hour.This report is 2 of 4 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the complaint condition is confirmed as the screwdriver was received with the distal tip broken and, due to the distal portion of the screwdriver being retained in the cannulated connecting screw, the remaining devices could not be disassembled.Review of the dhrs for the known lot numbers showed that there were no issues during the manufacture of these products that would contribute to this complaint condition.The returned devices are part of the trochanteric fixation nail advanced (tfna) system.The connecting screw secures the insertion handle to all the tfna nails, by threading into the threads on the proximal end of the nail through use of the ball hex screwdriver.The ball hex screwdriver was received with a transverse break at the transition of the distal ball hex to the shaft of the screwdriver.The distal tip was received but could not be removed from the connecting screw.The screwdriver shaft also shows a slight bend over the length of the shaft.The proximal hex shows worn edges.The insertion handle, connecting screw, and nail were received assembled together.The lock prong of the nail shows bending that was likely a result of the blade removal.Due to the distal portion of the screwdriver being retained in the cannulated connecting screw the devices could not be disassembled.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the screwdriver is already broken which has resulted in an inability to disassemble the devices form the nail.A review of the current design drawing and manufactured revision, if known, was performed for the ball hex screwdriver, the ball hex screwdriver shaft , the insertion handle, the nail, and the connecting screw.For 03.037.112, 04.037.112s, and 03.037.010, 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 leads to difficulties to disassemble the instruments from the implant.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.The final root cause has been identified as material : labeling.A lack of details on handling soft tissue pressure during removal of the insertion handle can lead to the observed difficulties disassembling the tfna screw (03.037.010) from handle (03.037.112) and nail (04.037.Yyys).The labeling does not state that soft tissue creates a potential impact for the ease of removal of the insertion handle.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: PERCUTANEOUS RADIOLUCENT INSERTION HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5719865
• MDR Text Key: 47209038
• Report Number: 3003875359-2016-10351
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.112
• Device Lot Number: 9316437
• Other Device ID Number: (01)10886982070562(10)9316437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 84