MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10 / TI CANN FRN / GT 380 / RIGHT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.033.068S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted.Investigation summary: the complaint device (10 / ti cann frn / gt 380 / right - sile) was not received for investigation.A photo investigation was performed based on the photos attached in notes & attachments section of pc titled ¿pc: (b)(4) x-ray (b)(6) 2021¿ and "pc: (b)(4) x-ray img_1832.Jpg (b)(6) 2021".The images were reviewed, and the complaint condition is not confirmed.After review of the x-ray provided, a displaced nonunion fracture is visible, the proximal fragments appear to be disassociated from the shaft of the bone.Additionally, a cannulated cancellous screws and a frn 10x380mm greater trochanter, right are present in the provided x-ray.Nevertheless, there are no notable defects identified and no signs of issue with the device(s) shown on the x-ray.A manufacturing record evaluation cannot be performed due to lot number being unknown.This complaint is not confirmed as a photo inspection does not show malfunction of the complaint device.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional information.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 history lot - lot # provided is not a valid number, therefore, the dhr could not be completed.If device is returned or lot number can be confirmed, the dhr will be revisited.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, the patient underwent removal of titanium cannulated femoral recon nail (frn) and four (4) unknown screws due to nonunion.This report is for one (1) 10 / ti cann frn / gt 380 / right - sile.This is report 1 of 5 for complaint pc # (b)(4).

• Brand Name: 10 / TI CANN FRN / GT 380 / RIGHT - SILE
• 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): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13361693
• Report Number: 2939274-2022-00244
• Device Sequence Number: 11174515
• Product Code: HSB
• UDI-Device Identifier: 10886982272010
• UDI-Public: (01)10886982272010
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 04.033.068S
• Device Catalogue Number: 04.033.068S
• Device Lot Number: L04658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/26/2022
• 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: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male