MAUDE Adverse Event Report: SYNTHES USA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Difficult To Position (1467)

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

Event Date 01/23/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Additional product code: hwc.This report is for an unknown trochanteric fixation nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device has not been explanted yet.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an insertion of a trochanteric fixation nail - advanced system (tfna) that the helical blade got halfway through the nail and would not advance or back out.It was noted that the set screw (the locking mechanism found inside the nail) migrated down slightly.It was unsure if the locking mechanism was the reason that the blade would not advance or back out.The surgeon tried to back out the helical blade with the extractor multiple times leading to a thirty to forty (30-40) minute surgical delay.While using the helical blade extractor to back out the helical blade, the tip of the extractor broke.Although the broken tip was retrieved, the blade was still stuck inside the patient.The locking mechanism was able to be removed and a new one was not implanted in its place.It was noticed that the lip of the locking mechanism was missing and it is unsure where the lip is.It was also noted that the helical blade inserter was not working correctly.Although the helical blade and the nail were left in the patient, the patient will need a revision surgery to either advance or remove the blade and the nail.It was additionally reported that although the nail and aiming arm were checked and noted to not have any issues with them, it is uncertain if they contributed to the product malfunctions noted in the procedure.It was reported that additional medical intervention (x-rays) were required and that additional blood may have been transfused.The patient status is stable (good) at this time but a revision surgery is required.This report is for an unknown trochanteric fixation nail.This is report 2 of 6 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

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

This is report 2 of 8 for (b)(4).

Manufacturer Narrative

A product development evaluation was completed: the product was not returned so only the complaint description could be investigated.From the complaint description, the locking mechanism found inside the nail migrated down slightly.If this is true, inserting the blade could cause a clamping action between the blade and the locking member.Additionally, the features of the prong are designed to straddle the blade when tightened.If the prong is advanced when there is no blade, there is no rotational constraint on the prong so that when the lock prong moved downward, it also rotated.This could cause the prong to be bent into the side of the head element hole, jamming the head element in the nail.Per the device labeling, while using the lock prong assembly the surgeon may find that due to inappropriate shipping or storage, the locking mechanism interferes with head element insertion and locking.It is unknown if the blade contributed to the complaint.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

This is report 2 of 9 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.

Event Description

It was reported the 85 mm helical blade and the 11mm x 170mm nail are still implanted in the patient.The patient was reportedly fully healed and has requested the implants be removed but the removal procedure has not yet occurred.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5440883
• MDR Text Key: 38314011
• Report Number: 2520274-2016-11065
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/23/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/18/2016; 03/09/2016; 03/24/2016; 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention