MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 95MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.395S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided for reporting.Additional device code ktt.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture additional medical/surgical intervention required.Device history records review was completed for part# 04.038.395s, lot# h483586.Manufacturing location: (b)(4), manufacturing date: nov 27, 2017, expiry date: oct 31, 2027.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 95mm sterile 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.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 that on (b)(6) 2018, patient underwent a femoral fracture procedure.During the procedure, a helical blade completely missed the nail.There was a surgical delay of about one and a half hour to get the nail out and the surgeon had to re-do the procedure using a smaller diameter nail and a new blade.The procedure was completed successfully with no impact to the patient.Patient outcome was reported as fine.This report is for one (1) tfna fenestrated helical blade 95mm - sterile.This is report 1 of 2 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 95MM - 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: 7508647
• Report Number: 2939274-2018-52151
• Device Sequence Number: 1224422
• Product Code: HSB
• UDI-Device Identifier: 10886982099273
• UDI-Public: (01)10886982099273
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.395S
• Device Catalogue Number: 04.038.395S
• Device Lot Number: H483586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/11/2018
• 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