MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC SPIRAL BLADE F/EXPERT RFN L75 TAN GOLD; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.013.047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event: it is unknown when the event occurred.Additional procode hwc.Product investigation has not been completed; no conclusion could be drawn, as no product was received.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.No ncrs were generated during the production of this device.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 hindfoot nail was implanted on (b)(6) 2017 in a diabetic patient.Eventually skin necrosed over spiral blade site and hardware was exposed.So a revision surgery was performed on (b)(6) 2017 to remove the blade and the wound was treated with a vacuum-assisted closure.The procedure was successfully completed with no surgical delay and the patient was stable after the surgery.This complaint involves one (1) device.This report is for a helical blade.This is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Add'l narrative: patient weight reported as (b)(6) it is unknown if that is (b)(6) pounds or kilograms.Part 04.013.047, lot h052871: date of manufacture: march 02, 2016.Place of manufacture: (b)(4).A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti spiral blade 75mm for ti retrograde femoral nails ¿ ex nonsterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Corrected data: initially reported as (b)(6) 2017 but should have been (b)(6) 2017.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: SPIRAL BLADE F/EXPERT RFN L75 TAN GOLD
• 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: 7176615
• Report Number: 2939274-2018-50139
• Device Sequence Number: 1212009
• Product Code: HSB
• UDI-Device Identifier: 10886982087485
• UDI-Public: (01)10886982087485(10)H052871
• Combination Product (Y/N): N
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: 04.013.047
• Device Catalogue Number: 04.013.047
• Device Lot Number: H052871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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: 81 YR