MAUDE Adverse Event Report: SYNTHES USA 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES; APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM

Catalog Number 223.414

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

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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 was 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 hardware removal was performed on (b)(6) 2016 due to implant site wound dehiscence.The patient underwent an open reduction internal fixation (orif) of the left fibula on (b)(6) 2015.Removed hardware included one locking compression (lcp) metaphyseal plate and seven unknown screws, all intact.The area was debrided and a 150mm cortex screw was implanted into the fibula for stability.The procedure was completed successfully with the patient in stable condition.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM LCP® METAPHYSEAL PLATE 14 HOLES
• Type of Device: APPLIANCES, FIXATION, NAIL/BLD/PL COMBO, MULTI COMP, METAL COM
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5459828
• MDR Text Key: 38975757
• Report Number: 2520274-2016-11279
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 223.414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• 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