MAUDE Adverse Event Report: SYNTHES (USA); NAIL, FIXATION, BONE

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during the implantation of a 9mm diameter, 400mm length nail it was observed that the patient¿s intramedullary canal was very narrow below the lesser trochanter.The surgeon, however, choose to continue impaction with the slide hammer using more force and fatigue occurred at the connecting screw.This resulted in a failure of the connecting screw to hold properly.It was also discovered that the nail had broken at the distal nail holes.Replacement devices were not available so extraction devices were to remove the broken nail.During the nail extraction, the extraction screw became stuck to the slide hammer and the nail became stuck to the slotted hammer.The surgeon then re-reamed the intramedullary canal.A 9mm, 420mm length nail was then implanted.There is no allegation of complaint against this nail.The surgeon then placed the distal pins and placed the dynamic hole proximally using a 4.00mm drill bit.During the insertion of two locking screws, there was difficulty obtaining proper tightness and security¿the screws appeared to have stripped/lost their thread and would not hold; however, there was no report of screw fragments being generated.A zero extension locking screw was implanted.There is no allegation of complaint against the zero extension locking screw.There was a 60 minute surgical delay due to the reported events.The surgery was completed and the patient is reportedly fine.This report is for two unknown locking screws.This report is 6 of 6 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by the reporter.Surgical delay was captured in report 1 for (b)(4).This report is for two unknown locking screws.Lot numbers were not provided by reporter.The diameter was reported as 4.9mm.Possible lengths and part numbers reported for this case are as follows: length 40mm part number 459.400; length 42mm part number 459.420; length 56mm part number 459.560; length 64mm part number 459.640.It is unknown if these screws were actually implanted on (b)(6) 2015 or if alternative device(s) was used.Device is not distributed in the united states, but is similar to device marketed in the usa.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.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

It was reported that after choosing the nail with a diameter of 9mm and length of 400, the surgeon inserted the start guide with the drill and then passed the drill bit to introduce the nail.When the surgeon inserted a nail below the minor trochanter, the surgeon saw that the channel was narrow and started to impact strongly with the hammer.There was fatigue with the connection screw and the surgeon realized that the holes at the distal end of the nail had broken.The surgeon decided to ream the intramedullary canal and use a nail with a diameter of 9mm and length of 420.The surgeon used a 4.0mm drill bit to perform the placement of the distal pins in the proximal part.When the surgeon was putting the bolts in there was some difficulty when the screw stripped/lost its thread.

• Type of Device: NAIL, FIXATION, BONE
• 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: 4704568
• MDR Text Key: 5714938
• Report Number: 2520274-2015-13134
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1