MAUDE Adverse Event Report: SYNTHES USA AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.019.008

Device Problem Failure to Align (2522)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products: 1x 04.016.038s / lot unk (multiloc phn ø9.5 r cann l160 tan); 1x 03.010.060 / unk lot (drill bit ø3.2 calibr l340 3flute f/03.0).Without a lot number, the device history record review and 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 on an event in (b)(6) as follows: it was reported that there was a surgery for right proximal humeral fracture on (b)(6) 2016.A surgeon put three multiloc screws into proximal holes.While inserting a distal lateral stopped screw, the surgeon drilled the proximal side hole but the screw interfered with the multiloc nail.He decided to address the hole later, and drilled another screw hole.The drilling penetrated inside cortex.After measurement, he inserted another screw.Then he drilled the proximal side hole again and this time they interfered a little however, was able to penetrated inside and the screw was inserted.Checking the side, the drilling was not off the targeted area.There is no information available about patient and surgical outcome.There was a surgical prolongation of 5 minutes reported.Please note: according to the description, the allegation is against the aiming devices as the screw/hole could not be placed as required.Therefore the aiming devices will be listed as part and the implants and the drill bit concomitant.This complaint involves 4 parts.Concomitant medical products: 1x unk screw; 1x 04.016.038s / lot unk (multiloc phn ø9.5 r cann l160 tan); 1x 03.010.060 / unk lot (drill bit ø3.2 calibr l340 3flute f/03.0).This report is 1 of 4 for (b)(4).

• Brand Name: AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6190005
• MDR Text Key: 62854882
• Report Number: 2520274-2016-15716
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• 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: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/20/2016
• 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
• Treatment: 1X 03.010.060 / UNK LOT (DRILL BIT Ø3.2 CALIBR L34; 1X 04.016.038S / LOT UNK (MULTILOC PHN Ø9.5 R CANN; 1X UNK SCREW