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

Model Number	04.038.395S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).Patient date of birth/age and weight were not provided for reporting.Date of event is unknown.Additional device product code used: ktt.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 patient underwent implant procedure on an unknown date.Post-operative, patient complained of pain.The surgeon planned to leave the blade implanted in the patient.However, when the patient reported feeling pain, the surgeon decided to exchange the blade for a smaller tfna lag screw.On (b)(6) 2018, patient underwent revision surgery.During the revision surgery, a blade was replaced with a tfna lag screw of a shorter length.The device was successfully exchanged with no reported delay.The patient was reported to be in great condition following the procedure.Information on implant procedure and the surgeon who performed it is unknown.Surgeon who performed revision surgery was reported to have been aware that the patient was implanted with a blade that was too long.It is unknown how the surgeon was made aware that the implanted blade was too long.This report is for one (1) tfna fenestrated helical blade 95mm.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 95MM
• 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: 7516090
• Report Number: 2939274-2018-52191
• Device Sequence Number: 11145246
• Product Code: HSB
• UDI-Device Identifier: 10886982099273
• UDI-Public: (01)10886982099273
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/20/2018

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: 04.038.395S
• Device Catalogue Number: 04.038.395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/15/2018
• 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