MAUDE Adverse Event Report: SYNTHES USA 4.5MM TI MULTILOC SCREW 4.5MM TI MULTILOC SCREW; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.019.016

Device Problem Fitting Problem (2183)

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

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is not expected to be returned for manufacturer review/investigation.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 a surgery for upper arm proximal fracture was performed on (b)(6) 2016.The patient had two parts of surgical neck fractured.Although the patient was small, the surgeon determined to use a multiloc screw.He fixed temporarily as he detained two drill bits.He then inserted the multiloc screw in the proximal d-hole but the screw was off the target area.He also checked the distal, and the drills were also off the targeted area.The surgery was prolonged about 20 minutes.No information about patient condition and outcome available.This complaint involves 2 parts.Concomitant reported part: 1x multiloc proximal humeral nail (part 04.016.035s lot unknown).This report is 1 of 2 for (b)(4).

• Brand Name: 4.5MM TI MULTILOC SCREW 4.5MM TI MULTILOC SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: 6168427
• MDR Text Key: 62389113
• Report Number: 2520274-2016-15664
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• 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
• Treatment: 04.016.035S, 1X MULTILOC PROXIMAL HUMERAL NAIL