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

Catalog Number 03.037.011

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 01/06/2017

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Event Description

It is reported during a trochanteric femoral nail-advanced (tfna) procedure to repair a fracture of the right femur on (b)(6) 2017, the surgeon implanted the nail and helical blade.X-rays taken after insertion revealed the blade missed the nail and went off to the side of it.The hybrid insertion handle and cannulated connecting screw were reassembled and the blade was removed.Surgeon attempted to reinsert the helical blade.The blade reportedly became stuck half way into the nail.Surgeon was unable to move it forward or backward.Surgeon then pulled the blade and nail together out of the fractured femur.The blade, nail, insertion handle, and connecting screw appear to be cold welded together and unable to be separated.Surgeon then implanted a standard trochanteric femoral nail (tfn) and blade with no issues.Second set of additional x-rays confirm tfn blade did insert into the tfn nail as expected.Surgery was delayed approximately four (4) hours due to this issue, but was completed successfully.This is report 1 of 4 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

A device history record review was performed on the part # 03.037.011, lot # 9899702.Manufacturing date: 06-05-2016, manufacturing location: (b)(4), business group: trauma.Device art nr 03.037.011 is a batch number controlled product, therefore no service history record review is possible.Device history record review result: no non conformance reports (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.The conclusion of the dhr review is that the final products manufactured in the production processes relevant to the device in the current complaint met inspection requirements, certification test values, and acceptance criteria.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

Product development investigation has been completed.A visual inspection, drawing review and device history records review were performed as part of this investigation.The four devices were returned stuck together.The nail was found to have drill markings on the outside of the device next to the proximal locking hole, which is consistent with the report that the blade missed the nail.The helical blade is confirmed to be stuck in the nail.The cannulated connecting screw was confirmed to be stuck to the nail and is retained inside the insertion handle.There appears to be material (metal and possibly bone material) inside the proximal locking hole of the nail which is obstructing the helical blade.The metal piece appears to be the locking mechanism of the nail.If the locking mechanism was not retracted prior to insertion of the helical blade, it would be likely to cause the complaint condition.Use of the returned devices is outlined in the tfn advanced proximal femoral nailing system screw only - technique guide.Relevant drawings were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The cause of the connecting screw becoming stuck to the nail is unable to be definitively determined.An investigation that was performed on previous complaints has 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 stating: ¿in case of difficulties to remove the connecting screw, push the insertion handle towards medial or lateral to neutralise soft tissue pressure.¿ in addition, based on the series of events it is possible that organic material remained inside the nail after the initial insertion and was not cleared prior to re-attachment to the connecting screw.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: HYBRID INSERTION HANDLE
• 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: 6278960
• MDR Text Key: 65792483
• Report Number: 2520274-2017-10279
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070272
• UDI-Public: (01)10886982070272(10)9899702
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2017

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: 03.037.011
• Device Lot Number: 9899702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/26/2017; 02/27/2017; 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR