MAUDE Adverse Event Report: SYNTHES HAGENDORF 130 DEG AIMING ARM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.013

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 02/12/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history record review could not be completed.The date of manufacture is unknown.(b)(4).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 there was a malfunction concerning a trochanteric fixation nail- advanced (tfna) procedure that was performed on (b)(6) 2017.It was reported that the nail was implanted, the lag screw was put in and then locked with the locking mechanism that goes over the locking screw.The surgeon spun the compression nut clockwise and everything was reportedly fine until the blade guide sleeve got stuck on the aiming arm.Reportedly the blade guide sleeve was fused to where the aiming arm connects to the insertion handle.As the surgeon could not remove the blade guide sleeve off of the aiming arm he was unable to insert the 5.0 locking screw located at the bottom of the nail.The surgeon had to remove the nail and because no alternative synthes devices were available for use, the surgeon had to change the surgical plan and implant a competitor's intertrochanteric nail system.There was a 30 - 45 minute delay due to the intraoperative events.The surgery was successfully completed and the patient was reported to be doing fine afterwards.No unplanned x-rays were required during the surgery.Although the implants are not available, the instruments will be returned for investigation.Concomitant medical products: 10mm / 130 degree titanium cannulated trochanteric fixation nail - advanced (part # 04.037.042s, lot # 9947627, quantity 1); lag screw (part # unknown, lot # unknown, quantity 1); buttress compression nut (part # unknown, lot # unknown, quantity 1); 5.0mm locking screw (part # unknown, lot # unknown, quantity 1).Insertion handle (part # unknown, lot # unknown, quantity 1).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.A review of the device history records has been requested.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

Device history records review was completed for part# 03.037.013, lot# 9475306.Manufacturing location: (b)(4), manufacturing date: jul 30, 2015.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product development investigation was completed.A visual inspection, device history record (dhr) review, functional test, and drawing review were performed as part of this investigation.The complaint condition is confirmed.The major thread form on the returned guide sleeve measured in several locations exceeds specification of max 16.52mm (micrometers om33p used as go gage set at 16.520mm).Relevant actions were taken to address the issue.During the investigation it was identified that a locking clip (part number 03.037.015 / lot number 9522592) was returned assembled to the aiming arm.This device is a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on this device.The returned devices are part of the trochanteric fixation nail advanced (tfna) system.The blade/screw guide sleeve (03.037.017) is connected to an aiming arm (03.037.013) via a locking clip (03.037.015) and the buttress compression nut (03.037.016).This provides a cannula to target the oblique hole of the tfna nail.This information is provided per the tfna technique guide.The blade/screw guide sleeve and the aiming are were received disassembled.Both devices showed light surface wear consistent with use and which would not impact functionality.The buttress compression nut was not received so complete assembly was not possible.However, at no time during partial assembly and disassembled did the devices bind.Thus, the complaint condition could not be replicated.It was observed that the red color coding is missing from the guide sleeve.Relevant drawings were reviewed.Guide sleeve: the major thread form on the returned guide sleeve measured in several locations exceeds specification of max 16.52mm (micrometers om33p used as go gage set at 16.520mm).Aiming arm: the mating inner diameter of the aiming arm was found to be with in the specification of 16.54 minimum at a minimum of 16.58mm (calipers ca102p).This device was determined to have not impacted the reported condition.During the investigation no unaddressed product design issues or discrepancies were observed that may have contributed to the complaint condition.Appropriate actions have been initiated to address the guide sleeve not fitting with the aiming arm due to the diameter of the sleeve being out of specification.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

Concomitant medical products: buttress compression nut (part # 03.037.016, lot # unknown, quantity 1), locking screw (part # 03.037.015, lot # unknown, quantity 1).

• Brand Name: 130 DEG AIMING ARM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6384141
• MDR Text Key: 69255228
• Report Number: 2520274-2017-10766
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.013
• Device Lot Number: 9475306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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
• Treatment: 04.037.042S, 10MM/130 DEG TI CANN TFNA 170MM - STL; UNKNOWN 5.0MM LOCKING SCREW, QTY 1; UNKNOWN BUTTRESS COMPRESSION NUT, QTY 1; UNKNOWN INSERTION HANDLE, QTY 1; UNKNOWN LAG SCREW, QUANTITY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR