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

Catalog Number 03.037.012

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Due to the malfunction, another nail had to be inserted, and surgery was extended by an hour.Device history records review was conducted.The report indicates that the: manufacturing site: (b)(4), manufacturing date: 07.Nov.2014.No ncrs 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 device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that a procedure took place, because of a cold fusion of the handle with the nail and the lack of stiffness of the ball, the screwdriver broke while trying to finish a surgery.The damage nail was taken out with a de insertion handle, and replaced with a (pfna) proximal femoral nail antirotation, this event happened while in the same surgical intervention.The screwdriver broke in 2 pieces, the distal ball of the screwdriver and the screwdriver without the distal ball.Patient outcome was good.Surgery was extended for 1 hour.This complaint involves 3 parts.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The complaint device is not expected to be returned to the synthes manufacturer for evaluation at this time.If the complaint device is received by the manufacturer, a follow-up report will be submitted.Narrative in initial medwatch report #(b)(4) was entered in error.The device history record review was completed and the results were reported in initial medwatch report #(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: date the subject device was received by manufacturer for evaluation.The subject device and is currently in the evaluation process and the results and pending completion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is 2 of 4 for (b)(4).

Manufacturer Narrative

As received condition of device: excessive force marks around the hexagon socket of the connecting screw, as well as the 11 mm hexagon profile below the handle grip.Product development event evaluation was completed: it was reported, that cold fusion occurred between the spherical head hex-screwdriver and the self retaining connecting screw.In consequence, the spherical end of the screwdriver broke off when trying to loosen the connecting screw.A note was added to the surgical technique, stating: ¿in case of difficulties to remove the connecting screw, push the insertion handle towards medial or lateral to neutralise soft tissue pressure.¿ 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.

Manufacturer Narrative

An investigation summary was performed.It was reported by the investigation of the complaint articles has shown that: the devices were received in an assembled condition; the insertion handle was still connected to the nail with the connection screw.The t-handle screwdriver was also send back and the complete spherical hexagon part is broken off, the fragment was enclosed.The manufacturing documents of all devices were reviewed and no complaint related issues were found.During the investigation it was possible to disassemble the devices with a straight standard hex-wrench by applying very high force.Afterwards it was possible to assemble and disassemble the devices as required.The review of the broken t-handle screwdriver has shown that the complete hexagon is broken off.The relevant dimensions at the fracture face cannot be verified anymore as the device did slightly twist at this point before it broke.The fracture face is homogenous, which indicates material conformity, and has the typical view of a forced rupture.Based on that, we conclude that the very high force that was applied onto the spherical shaped tip of the t-handle screwdriver during the attempt of loosening the connection screw did lead to the breakage of the device.However, based on the provided information we are not able to determine what finally caused the jamming between the nail, the insertion handle and the connection screw.One reason is possibly very strong tightening of the connection screw during assembling, which would explain the visible deformations at the broken hexagon and as well by the visible marks in clockwise direction of a wrench at the upper hexagon below the handle.An investigation that was performed on previous complaints has shown that also shown that soft tissue pressure can also lead to a jamming of the devices.Therefore a note was added to the tfna surgical technique guide, stating: ¿in case of difficulties to remove the connecting screw, push the insertion handle towards medial or lateral to neutralize soft tissue pressure.¿ 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: COMPLETE 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5765066
• MDR Text Key: 48646306
• Report Number: 3003875359-2016-10393
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/15/2016

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: 03.037.012
• Device Lot Number: 9167523
• Other Device ID Number: (01)10886982069306(10)9273600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/29/2016; 09/08/2016; 09/21/2016; 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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: 85 YR
• Patient Weight: 64