MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 95MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.395S
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight was not provided for reporting.Date of event is unknown.Additional device product code: ktt.Device is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales representative.(b)(4).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, a trochanteric femoral nail advance (tfna) helical blade was removed due to a cut out in the femoral head.It was replaced with a tfna screw.Initial implant date is unknown.Surgical delay and patient outcome were unknown.Concomitant devices reported: tfna nail (part # unknown, lot # unknown, quantity # 1), distal locking screw (part # unknown, lot # unknown, quantity # 1).This report is for one (1) tfna fenestrated helical blade 95mm - sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Initial reporter name, telephone, email, and occupation.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: TFNA FENESTRATED HELICAL BLADE 95MM - 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: 7868551
• Report Number: 2939274-2018-53751
• Device Sequence Number: 14040610
• Product Code: HSB
• UDI-Device Identifier: 10886982099273
• UDI-Public: (01)10886982099273
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

1 Device 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: 04.038.395S
• Device Catalogue Number: 04.038.395S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 09/13/2018