MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.013.452S

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

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Additional product code hwc.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on an unknown date, patient underwent removal of one (1) titanium retro/ antegrade femoral nail and four (4) titanium locking screws due to pain.Patient outcome was unknown.This complaint involves five (5) devices.This report is for (1) 10mm ti cann retro/antegrade femoral nail-ex/360mm-sterile.This is report 1 of 5 for (b)(4).

• Brand Name: 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10843709
• MDR Text Key: 216363676
• Report Number: 2939274-2020-05154
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087874
• UDI-Public: (01)10886982087874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.013.452S
• Device Catalogue Number: 04.013.452S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0MM TI LCKN SCRW W/ T25 STRDRV 42MM FOR IM NALS
• Patient Outcome(s): Required Intervention