MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.008.016S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Event date: unknown when non-union began.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) used for: hardware removal of a hind-foot nail took place on (b)(6) 2018 due to nonunion of subtalar joint.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review not available for reporting at this time.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.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 a hardware removal of a hind-foot nail took place on (b)(6) 2018 due to nonunion of subtalar joint.The nail was removed, iliac bone graft was taken to graft the nonunion and 6.5/7.3 cannulated screws were inserted for fixation.Procedure completed successfully with no delay in surgery.This complaint involves four (4) devices.This report is 1 of 4 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: part: 04.008.016s; lot: 7792858; manufacturing location: selzach; supplier: (b)(4); release to warehouse date: november 03, 2014 non-sterile 04.008.016 / 7792858 was manufactured in us, monument.Manufacturing date: september 17.2014.Part #: 04.008.016, lot#: 7792858, 10mm ti hindfoot arthrodesis cann nail-ex 180mm/right ¿ qty: 6.No non-conformance reports (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.Components parts reviewed: raw material part 21012 bp80 lot 7691972.Raw material provided by perryman company.Certified test report for titanium ingot received from perryman meet specification.Raw material receiving/putaway checklist meet specification.Inspection sheet for in-process acceptance sheet met inspection acceptance criteria.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

• Brand Name: 10MM 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: 7438747
• Report Number: 2939274-2018-51774
• Device Sequence Number: 13807162
• Product Code: HSB
• UDI-Device Identifier: 10886982087171
• UDI-Public: (01)10886982087171
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2018

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 Model Number: 04.008.016S
• Device Catalogue Number: 04.008.016S
• Device Lot Number: 7792858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 82