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

Device Problem Failure to Align (2522)

Patient Problem Sedation (2368)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient id is not available for reporting.This report for one unknown drill bit.Part and lot numbers were not provided by the reporter.Other--udi: unknown part number, udi is unavailable for reporting.Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(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

Synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during surgery to treat a proximal humeral fracture on (b)(6) 2016, the surgeon inserted the nail by hammering because his attempt at manual insertion was not successful.While attempting to insert the screw, the drill bit interfered with the nail.The surgeon removed the nail and found the connection portion of the nail was broken and the insertion handle was not properly orientated.The surgeon then inserted a different nail but he could not insert the nail deep enough into the patient¿s bone and the proximal part of the nail protruded approximately 5mm from the bone.The patient has a limited range of motion as a result of the nail protrusion.The surgery was delayed 90 minutes due to the reported events.The surgeon commented that the events were due to his usage of the hammer and not a product problem.The surgeon is planning to remove the nail when synostosis of the fracture is confirmed.This report for one unknown drill bit.This report is 2 of 6 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: 5493336
• MDR Text Key: 40113520
• Report Number: 2520274-2016-11586
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• 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?: Yes
• Date Manufacturer Received: 02/24/2016
• 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: 16 YR
• Patient Weight: 50