MAUDE Adverse Event Report: SYNTHES (USA); BIT, DRILL

Device Problem Failure to Align (2522)

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

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).This report is for one unknown drill bit.Part and lot numbers were not provided by reporter.Device is an instrument and is not implanted/explanted.(b)(4) unanticipated x-rays related to complained events.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

It was discovered during a proximal femur fracture surgery on (b)(6) 2015 after the jig was removed, the wire for the helical blade inserter and the helical blade had passed anterior to the nail and the guide holes from the drill bits.The surgeon had reportedly checked the alignment of the helical blade insertion cannula both before and after the insertion and all items aligned appropriately.Initially during the procedure the surgeon attempted to perform an open reduction internal fixation (orif) with a dynamic hip screw (dhs).The surgeon was able to pass the dhs guide pin without incident but was unable to get the angle he desired due to soft tissue constraints because of the patient's size.Then the surgeon converted to the trochanteric fixation nail advanced (tfna) for fixation in the above described event.Once it was discovered that the wire and helical blade had passed anterior to the nail the surgeon removed the implants and successfully completed the surgery with a trochanteric fixation nail (tfn).There was a 60 minute surgical delay related to the complained events.This report is for one unknown drill bit.This report is 10 of 10 for (b)(4).

• Type of Device: BIT, DRILL
• 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: 5088567
• MDR Text Key: 26226281
• Report Number: 2520274-2015-16000
• Device Sequence Number: 1
• Product Code: HTW
• 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,health
• Reporter Occupation: Other
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• 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
• Date Manufacturer Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR