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

Model Number	04.038.185S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the image provided.The image was reviewed, and the complaint condition cannot be confirmed.There is no evidence of any defects with the tfna fenestrated screw.A valid lot number was not provided.If a valid lot number becomes known, a manufacturing record evaluation will be performed.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed during the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 a trochanteric fixation nail-advanced (tfna) construct was successfully removed on (b)(6) 2021 due to lag screw cut out.X-ray taken on an unknown date revealed that the lag screw had completely cut out of the femoral head.The surgeon who implanted the device on (b)(6) 2021 said that the femur had fallen into varus collapse leading to cut out.Patient was revised to a total hip.No further information provided.This report is for one (1) tfna fenestrated screw 85mm - sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 85MM - 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
• MDR Report Key: 12632934
• Report Number: 2939274-2021-06112
• Device Sequence Number: 16967182
• Product Code: HSB
• UDI-Device Identifier: 10886982098719
• UDI-Public: (01)10886982098719
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: 04.038.185S
• Device Catalogue Number: 04.038.185S
• Device Lot Number: 77P6482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/125 DEG TI CANN TFNA 400/RIGHT - SILE; 5.0 TI LCKNG SCREW T25 SD 42 F/IM NAIL-S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR