MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T25 STRDRV HINDFOOT ARTHRO NAIL-EX SPIRAL BLADE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.008.000
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.Date of event: unknown when non-union began.Expiration date: unknown.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.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 3 of 4 for (b)(4).

• Brand Name: TI END CAP T25 STRDRV HINDFOOT ARTHRO NAIL-EX SPIRAL BLADE
• 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: 7438740
• Report Number: 2939274-2018-51781
• Device Sequence Number: 16563609
• Product Code: HSB
• UDI-Device Identifier: 10886982087126
• UDI-Public: (01)10886982087126
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• 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: 04.008.000
• Device Catalogue Number: 04.008.000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2018
• Initial Report FDA Received Date: 04/17/2018
• 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