MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number	04.038.300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed on part # 04.038.300, lot # 7986831: release to warehouse date: 23 april 2015, manufacturing site: (b)(4).A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 100mm non 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 patient the patient underwent a removal of a tfn-advanced¿ proximal femoral nailing system (tfna) due to a non-union and infection on (b)(6) 2017.Cultures were taken prior to the procedure and it was determined the hip fracture was an infected non-union.One (1) 12mm/130 degree titanium cannulated tfna 380mm/left-sterile and one (1) tfna helical blade 100mm were removed intact.The patient received antibiotic cement over a rush rod placed in the femur.No surgical delays.No reported patient harm.Date of implant is unknown.This is report 2 of 2 for complaint (b)(4).

• Brand Name: TFNA HELICAL BLADE 100MM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6419129
• Report Number: 3003506883-2017-10040
• Device Sequence Number: 10897618
• Product Code: HSB
• UDI-Device Identifier: 10886982099020
• UDI-Public: (01)10886982099020(10)7986831
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

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 Catalogue Number: 04.038.300
• Device Lot Number: 7986831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention