MAUDE Adverse Event Report: SYNTHES USA 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM; BIT,DRILL

Catalog Number 03.010.104

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.(b)(6).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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a standard surgical technique insertion of reconstruction screws into the a2fn femoral nail it was noted that the 2 x 3.2mm guide wires were not passing through the nail holes but rather anterior to the nail.The insertion handle, aiming arm and trocar assembly had been tested for alignment prior to insertion into the patient and the 3.2mm wires passed through the center of the nail holes as it should.The whole nail was extracted and tested again for alignment outside of the patient, the nail was firmly secured to the insertion handle and the guide wires passed through the center of the reconstruction holes in the nail using the aiming arm and trocar assembly.Upon re-insertion of the nail it was found that the 3.2mm wire passed through the nail when in a direct horizontal plane relative to the floor.Upon trying to achieve better ante-version of the guide wires up into the center of the femoral neck the nail insertion handle and aiming arm assembly were rotated downward towards the floor.The surgeon was sure surgeons that there was no significant soft tissue tension on the trocar assembly from the soft tissue incision they had created in the proximal lateral femur for entry of the trocar assembly although it was noted that this incision was slightly anterior to the direct lateral plane of the femur.The surgeon did tend to hold the carbon fiber aiming arm distally to rotate the nail around rather than utilizing the stainless steel aiming arm portion of the assembled jig to rotate the nail despite sales rep recommendations otherwise.Despite several attempts to pass the wires through the nail they continually missed the nail anteriorly when inserting into the more anteverted position into the femoral head/neck.The decision was made by the surgeon to remove the a2fn implants and implant a pfna nail instead.This went ahead without incident until during distal locking one of the short 4.2mm drill bits (part 03.010.104 - lot number unknown) had its tip broken while drilling through the circular distal nail hole.The drill tip fragment was deemed irretrievable so it was left insitu in the patient.The distal locking was completed using the other slotted distal screw hole with one 5.0mm distal locking bolt making up the construct.This delayed the surgery for 60 more minutes until new method of fixation chosen.At day one post-op, no further adverse reports received regarding this patient's recovery at this stage.Concomitant parts reported: 1x aiming arm 03.010.350 lot.7681275, 1x insertion handle 03.010.351 lot.3589850; 1x protection sleeve 03.010.353 lot.80000787; 1x drill sleeve 03.010.354 lot.3459693.This report is 3 of 3 for (b)(4).

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5947258
• MDR Text Key: 54626467
• Report Number: 2520274-2016-14504
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• 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: 1X AIMING ARM 03.010.350 LOT. 7681275; 1X DRILL SLEEVE 03.010.354 LOT. 3459693; 1X INSERTION HANDLE 03.010.351 LOT. 3589850; 1X PROTECTION SLEEVE 03.010.353 LOT. 80000787
• Patient Outcome(s): Required Intervention