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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Type  Injury  

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 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).

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
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380
• MDR Report Key: 7176615
• MDR Text Key: 96810535
• Report Number: 2939274-2018-50139
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087485
• UDI-Public: (01)10886982087485(10)H052871
• Combination Product (y/n): N
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.013.047
• Device Catalogue Number: 04.013.047
• Device Lot Number: H052871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR