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

Model Number	04.038.395S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: only event year is known.Common device name: additional device product codes: ktt.Device available for evaluation: 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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(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 or Problem Description
It was reported that on an unknown date, the patient underwent a total hip following cutout of the trochanteric fixation nail advanced (tfna) fenestrated helical blade into the joint.Originally, the patient had an open reduction internal fixation (orif) on left hip on (b)(6) 2020.The trochanteric fixation nail advanced (tfna) long nail, distal locking screws and helical blade were removed easily.None of the hardware was broken.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.Concomitant device reported: titanium cannulated trochanteric fixation nail advanced (part number 04.037.259s, lot unknown, quantity 1), 5.0 distal locking screws (part number unknown, lot unknown, quantity unknown).This report involves one (1) tfna fenestrated helical blade 95mm ¿ sterile.This is report 1 of 1 for (b)(4).

• 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: 10211719
• Report Number: 2939274-2020-03036
• Device Sequence Number: 2095417
• Product Code: HSB
• UDI-Device Identifier: 10886982099273
• UDI-Public: (01)10886982099273
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 04.038.395S
• Device Catalogue Number: 04.038.395S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; UNK - SCREWS: NAIL DISTAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR