MAUDE Adverse Event Report: SYNTHES (USA); CERCLAGE, FIXATION

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient height is 157cm.This report is for an unknown quantity of unknown cerclage wires.Part and lot numbers were not available for reporting.Other number¿udi: part number unknown, udi is unavailable.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 europe reports an event in (b)(6) as follows: it was reported that the patient was initially treated with a locking compression plate (lcp) for an infected femur fracture.The patient needed further treatment on (b)(6) 2016 due to infection-related right femoral periprosthetic pseudarthrosis.The treatment comprised cancellous bone graft from the left posterior upper iliac crest, pseudarthrosis revision and resection.The implanted lcp-plate and hardware remained in situ at that time.The patient underwent another revision procedure on (b)(6) 2016 and the plate and associated hardware were explanted.This event is captured and reported under linked complaint (b)(4).This report is for an unknown quantity of unknown cerclage wires.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Date of report was initially reported as oct 21, 2016, but should have been oct 06, 2016 as per the received update.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.

• Type of Device: CERCLAGE, FIXATION
• 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: 6118540
• MDR Text Key: 60621890
• Report Number: 2520274-2016-15485
• Device Sequence Number: 1
• Product Code: JDQ
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• 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 Weight: 45