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

Model Number	04.008.216S
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
Date of event: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr review was completed.Item: 04.008.216s.Lot: h064699.Mfg qty: 6.Mfg date: 01 apr 2016.Mfg location: (b)(4).Exp date: 28 feb 2025.Product was inspected and passed.There were no ncs or reworks generated during the manufacture of this lot.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient was implanted with one (1) 12 mm hindfoot arthrodesis cannulated nail, one (1) spiral blade, one (1) end cap, two (2) unknown 5 mm locking screws, and one (1) unknown 6 mm locking screw on (b)(6) 2017.On unknown date, patient developed avascular necrosis (avn) and non-union.Patient was returned to surgery on (b)(6) 2018 where all hardware was removed.Patient was revised to one (1) 4 mm cannulated screw and one (1) 6.5 mm cannulated screw.Surgery was completed successfully with no delay.Patient status reported as stable.This report is for one (1) 12 mm hindfoot arthrodiesis cannulated nail.This is report 1 of 5 for (b)(4).

• Brand Name: 12MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-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: 7698347
• Report Number: 2939274-2018-52950
• Device Sequence Number: 19092705
• Product Code: HSB
• UDI-Device Identifier: 10886982087232
• UDI-Public: (01)10886982087232
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 02/28/2025
• Device Model Number: 04.008.216S
• Device Catalogue Number: 04.008.216S
• Device Lot Number: H064699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 71