MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 90MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hwc.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was performed for part #: # 456.303 lot # 7390079: release to warehouse date: 20 may 2013, manufacturing site: (b)(4): a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0 mm ti helical blade 90 mm 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 a patient underwent revision surgery on (b)(6) 2017 to remove a trochanteric fixation nail (tfn) system for a conversion to a total hip replacement.The patient was initially implanted on an unknown date.Post-operatively the patient had fallen and broke her femur again.Cables were implanted to hold the bone together before removal of nail, then continued on to complete the hip replacement.During the revision the tfn nail, helical blade, locking screw and end cap were easily removed, whole and intact.There was no surgical delay.No patient harm was reported.The procedure was successfully completed.No device malfunctions occurred during the revision.The patient received a total hip replacement.Patient outcome was reported as stable.This report is for one (1) 11.0 mm ti helical blade 90 mm.This is report 2 of 4 for complaint (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 90MM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 7002809
• Report Number: 3003506883-2017-10253
• Device Sequence Number: 19111981
• Product Code: HSB
• UDI-Device Identifier: 10886982226679
• UDI-Public: (01)10886982226679(10)7390079
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• 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): 10/10/2017

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: 456.303
• Device Catalogue Number: 456.303
• Device Lot Number: 7390079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 52