MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 90MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.190
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Additional device product code: ktt.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.Reporter contact number was not provided.(b)(4) used to capture additional medical/surgical intervention required.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, 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 (b)(6) 2018, patient underwent trochanteric fixation nail advanced (tfna) hardware removal procedure for superior cut out of lag screw in femoral head.No complications in surgery.All the hardware was removed.Patient and surgery outcome were not reported.Concomitant devices reported: tfna nail (part # 04.037.027s, lot # unknown, quantity 1); 5.0mm ti locking screw (part # 04.005.526, lot # unknown, quantity 1; 5.0mm locking screw(part # 04.005.528, lot # unknown, quantity 1).This report is for one (1) tfna fenestrated screw 90mm.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 90MM
• 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: 7439750
• Report Number: 2939274-2018-51724
• Device Sequence Number: 13766170
• Product Code: HSB
• UDI-Device Identifier: 10886982098726
• UDI-Public: (01)10886982098726
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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): 03/26/2018

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: 04.038.190
• Device Catalogue Number: 04.038.190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/18/2018
• 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: 88 YR