MAUDE Adverse Event Report: SYNTHES, USA; SCREW, FIXATION, BONE

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for three (3) unknown - titanium 4.9mm screw.Exact date of implant procedure is unknown.The complainant part is not expected to be returned to manufacturer.Pma/510(k) number is unknown as this report is for three (3) unknown- titanium 4.9mm screw.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.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.

Event Description

It was reported that a patient with a history of sweet's disease and obesity had a tibial nail implanted 15 years ago on an unknown date.Recently, the patient began to experience pain in the ankle; the surgeon decided to remove the implants.On (b)(6) 2016, patient underwent procedure for implant removal.One (1) titanium solid tibial nail, three (3) titanium 4.9mm screw, one (1) stainless steel 6-hole dynamic compression plate, six (6) 3.5mm cortex screws, and one (1) 4.5mm cannulated screw were removed intact.Patient was not revised with any new implants.There was no surgical delay and procedure was completed successfully.Patient status was reported as stable.This report is for three (3) unknown - titanium 4.9mm screw.This is report 2 of 5 for (b)(4).

Manufacturer Narrative

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.

• Type of Device: SCREW, FIXATION, BONE
• 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: 5943128
• MDR Text Key: 54444312
• Report Number: 2520274-2016-14491
• Device Sequence Number: 1
• Product Code: JDS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2016
• 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: 43 YR
• Patient Weight: 126