MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.390S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Health effect clinical code (b)(4) used to capture code injury.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 a patient had a long trochanteric fixation nail-advanced (tfna) nail implanted 2 weeks ago.The patient fell postoperatively and implants needed to be removed and revised to a hemiarthroplasty.The procedure and the patient outcome were unknown.This report is for one (1) tfna fenestrated helical blade 90mm - sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 90MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14599846
• Report Number: 2939274-2022-02087
• Device Sequence Number: 14996647
• Product Code: HSB
• UDI-Device Identifier: 10886982099259
• UDI-Public: (01)10886982099259
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 04.038.390S
• Device Catalogue Number: 04.038.390S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/130 DEG TI CANN TFNA 420/LEFT - SILE; UNK - SCREWS: NAIL DISTAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown