MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; ROD,FIXATION,INTRAMEDULLARY

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.510k: this report is for an unknown tfn helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant.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 during an unknown hip procedure on (b)(6) 2018, the trochanteric fixation nail (tfn) helical blade would not align correctly during insertion through the guide.Surgeon continued with the procedure by manipulating the guide, which allowed the tfn blade to pass.Procedure was completed successfully with no delay.Concomitant devices reported: tfn nail (part number unknown, lot number unknown, quantity 1), guide (part number unknown, lot number unknown, quantity 1).This report is for one (1) unknown tfn helical blade.This is report 1 of 1 for (b)(4).

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.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: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7541974
• MDR Text Key: 109176876
• Report Number: 2939274-2018-52301
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1