MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 85MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.085S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Implant date is an unknown date in (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 or Problem Description
It was reported that on an unknown date in (b)(6) 2017, patient underwent an implant procedure.On an unknown date post-operative, the blade cut through the femoral head.On (b)(6) 2018, patient underwent a trochanteric fixation nail advanced (tfna) removal procedure due to the implant failure.During the procedure, one (1) sterile tfna screw 85 mm, and one (1) sterile 11 mm/130 degree ti cannulated tfna 360 mm/right were removed.There was no surgical delay.The procedure was completed successfully with the patient outcome reported as good.Concomitant device(s) reported: proximal femoral nail (part# 04.037.156s, lot# unknown, quantity: 1).This report is for one (1) tfna screw 85 mm - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA SCREW 85MM - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7337819
• Report Number: 2939274-2018-51047
• Device Sequence Number: 95201
• Product Code: HSB
• UDI-Device Identifier: 10886982098450
• UDI-Public: (01)10886982098450(17)EXPIRATIONDATEUNKNOWN(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.085S
• Device Catalogue Number: 04.038.085S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 113