MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM; NAIL,FIXATION,BONE

Model Number	04.034.649S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Photo investigation: the device was not returned.A photo-investigation was performed on the x-ray.Upon investigating the x-ray provided, the complaint condition cannot be confirmed.Based on the provided x-ray, the infection cannot be confirmed on the tibial nail.The root cause of the complaint condition cannot be confirmed based on the available 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.Conclusion: the complaint condition cannot 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 lot 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 (b)(6) 2021, patient underwent a hardware removal due to infection.The hardware removal of a synthes tibial nail and unknown total knee implants.The tibia and the knee were grossly infected.The tibial nail was placed at an unknown time and place.The hardware was removed successfully, and two humeral nails were wrapped in cement and used as antibiotic spacers.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves four (4) devices.This report is for (1) 12mm ti cann tibial nail-ex w/prox bend 345mm.This report is 1 of 4 (b)(4).

• Brand Name: 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11890398
• Report Number: 2939274-2021-02614
• Device Sequence Number: 19781332
• Product Code: JDS
• UDI-Device Identifier: 10886982095503
• UDI-Public: (01)10886982095503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 04.034.649S
• Device Catalogue Number: 04.034.649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/26/2021
• 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: 55 YR
• Patient Weight: 89