MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELBOW HINGE FIXATOR; APPLIANCE,FIXATION,NAIL

Model Number 394.055

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/04/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Additional device product code: lxt.Implanted on an unknown date the week of (b)(6) 2018.Device unscrewed and fell out of a patient on (b)(6) 2018.(b)(4) used to capture additional medical/surgical intervention required.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 an elbow hinge fixator somehow unscrewed and fell out of a patient on (b)(6) 2018.Luckily the patient was still in recovery at the hospital and the surgeon was able to implant the patient with a new elbow hinge fixator that same day.The patient was originally implanted with the hinge on an unknown date the week of (b)(6) february.No information is available about the original procedure.The march 4th procedure was reported to be successfully completed with no complications or delays.The patient was reported to be in good condition following the procedure.This is report 1 of 1 for complaint (b)(6).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part no.: 394.055, lot no.: l270608.Manufacturing location: bettlach.Release to warehouse date: 30.Mar.2017.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: customer quality conducted an investigation of the returned device.The returned 394.055 lot number l270608 elbow hinge fixator shows some markings, discoloration, and other signs of wear but nothing that would impair its function.The device functions as designed.A visual inspection, drawing review, and dhr review were performed as part of this investigation.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.The device was reported to have fallen apart from the patient postoperatively.This complaint is unconfirmed.The device was received intact without any missing components or signs of having fallen apart.The complaint condition cannot be replicated as no mating parts were returned.A dimensional inspection was not performed as the complaint condition could not be identified with a specific feature.Drawing was reviewed for this investigation.The dcrm document adequately addresses the complaint condition.There were no issues found with the returned device therefore a corrective action is not warranted.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.

• Brand Name: ELBOW HINGE FIXATOR
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7391945
• MDR Text Key: 104171704
• Report Number: 2939274-2018-51398
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982199478
• UDI-Public: (01)10886982199478(10)L270608
• Combination Product (y/n): N
• PMA/PMN Number: K090658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 394.055
• Device Catalogue Number: 394.055
• Device Lot Number: L270608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention