MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LCKNG SCREW T25 SD 40 F/IM NAIL-S; SCREW, FIXATION, BONE

Model Number	04.005.530S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Without a valid lot number the device history records review could not be completed.Complainant device is not expected to be returned for manufacturer review/investigation.Investigation summary: background: it was reported that on an unknown date, during an orthopedic procedure, after the tfna implanted on (b)(6) 2021, the femur was broken below distal interlocking screw in nail.Nail, lag screw, and distal interlocking screw were removed on (b)(6) 2021 and swapped out with new tfna exchange nail, lag screw and new interlocking screw distally.The procedure successfully completed.Patient outcome is unknown.This complaint involves three (3) devices.(b)(4).Customer quality investigation: the device was not returned.A photo-investigation was performed on the images ¿tfn nail 5.29.2021.Jpg", ¿img_7894.Jpg¿, ¿femur fracture 5.29.2021.Jpeg¿, and ¿lag screw 5.29.2021.Jpg¿.Upon inspecting the images provided, no issues were noted with the implant(s) that would contribute to the adverse event and therefore is unconfirmed.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.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Conclusion: the complaint condition could not be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.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, during an orthopedic procedure, after the tfna implanted on (b)(6) 2021, the femur was broken below distal interlocking screw in nail.Nail, lag screw, and distal interlocking screw were removed on (b)(6) 2021 and swapped out with new tfna exchange nail, lag screw and new interlocking screw distally.The procedure successfully completed.Patient outcome is unknown.This complaint involves three (3) devices.This report is for one (1) 5.0 ti lckng screw t25 sd 40 f/im nail-s.This report is 3 of 3 for (b)(4).

• Brand Name: 5.0 TI LCKNG SCREW T25 SD 40 F/IM NAIL-S
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12060573
• Report Number: 2939274-2021-03197
• Device Sequence Number: 14507804
• Product Code: HWC
• UDI-Device Identifier: 10886982085993
• UDI-Public: (01)10886982085993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.530S
• Device Catalogue Number: 04.005.530S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 82