MAUDE Adverse Event Report: SYNTHES USA 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE; N/A

Catalog Number 04.019.038S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4): the complainant reported bone fragment of proximal epiphysis started inverting and de-rolling.Then after one week, the surgeon noted a¿ falling image of the bone fragment".At the time of this review, it is unknown which implant penetrated the greater tubercle and there is no allegation of a device malfunction.Should further information become available this determination will be reviewed accordingly.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

It was reported that a multiloc proximal humeral nail, three multiloc screws and two self-tapping locking screw were used in a surgery for proximal humeral surgical neck fracture on (b)(6) 2016.A surgeon could not use ascending screws because the patient was small.The surgeon used three multiloc screw (ø4.5 l38 tan), a locking screw (ø3.5 self-tap l30 tan) and a locking screw (ø3.5 self-tap l32 tan).There was nothing wrong with an insertion portion of the nail.As he checked x-ray photography of the next day, he confirmed that bone fragment of proximal epiphysis started inverting and de-rolling.Then after one week, he confirmed a falling image of the bone fragment.The patient did not feel so much pain, probably because the patient has dementia.From ct images, he found a mark that the implant penetrated a greater tubercle.A surgery to remove the nail and replace it with an artificial shoulder bone head is planned on (b)(6) 2016.Complaint involves 6 parts.This report is 3 of 6 for (b)(4).

Manufacturer Narrative

(b)(4).Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE
• Type of Device: N/A
• 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: 6149985
• MDR Text Key: 61590699
• Report Number: 2520274-2016-15604
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.019.038S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR