MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/LT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.008.266S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Event year is reported as 2020; however exact date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Investigation summary: device history lot; part # 04.008.266s, synthes lot # h064698, supplier lot # na, release to warehouse date: apr 07, 2016, expiration date: feb 28, 2020, manufactured by synthes (b)(4), no ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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) 2020, the patient underwent removal of the hindfoot nail followed by implantation of the max-frame system due to an infected nonunion.Initially, the patient was implanted with a hindfoot arthrodesis nailing system on (b)(6) 2020.It was unknown if the removal surgery completed successfully.The patient outcome unknown.This complaint involves seven (7) devices.This report is for (1) 12mm ti hindfoot arthrodesis cann nail-ex 180mm/lt-sterile.This report is 1 of 7 for (b)(4).

• Brand Name: 12MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/LT-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10969380
• Report Number: 2939274-2020-05487
• Device Sequence Number: 16361546
• Product Code: HSB
• UDI-Device Identifier: 10886982087263
• UDI-Public: (01)10886982087263
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 11/11/2020

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 Expiration Date: 02/28/2020
• Device Model Number: 04.008.266S
• Device Catalogue Number: 04.008.266S
• Device Lot Number: H064698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS: HINDFOOT ARTHRODESIS NAIL; UNK - NAIL HEAD ELEMENTS: HINDFOOT SPIRAL BLADE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention