MAUDE Adverse Event Report: SYNTHES USA 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 60MM; NAIL, FIXATION, BONE

Catalog Number 212.124

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(6).(b)(4).The product will not be returned.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

It was reported that originally on (b)(6) 2015 the patient went through an open reduction internal fixation procedure for a right proximal tibia fracture and was implanted with one (1) medial proximal tibia plate, one (1) locking compression (lcp) proximal tibia plate, three (3) cortex screws and nine (9) locking screws.The patient went in for a post-operative follow up visit and it revealed an infection of right proximal tibia.On (b)(6) 2016, a decision was made to remove all hardware and treat the patient with antibiotics; all of the hardware was removed intact.It was reported that the procedure was completed successfully with no surgical delay and the patient's status was stable.This report is 13 of 14 for com-(b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 60MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5890166
• MDR Text Key: 52573459
• Report Number: 2520274-2016-14246
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 212.124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 70