MAUDE Adverse Event Report: SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 95MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.304S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used for: the complaint indicated that the patient had a non-union and the helical blade cut-out of the superior portion of the femoral head requiring additional surgical intervention.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 hardware removal and revision of a trochanteric fixation nail (tfn) was performed on (b)(6) 2018 due to non-union and helical blade cut-out of the superior portion of the femoral head.The original tfn procedure was performed on (b)(6) 2016 by a different surgeon at a different facility.All tfn implants were removed intact and without incident.The patient was revised to a biomet total hip system.Surgery was completed successfully and patient outcome was satisfactory.This complaint involves one part.This report is 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 95MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester 19380
• MDR Report Key: 7244277
• Report Number: 2939274-2018-50521
• Device Sequence Number: 164985
• Product Code: HSB
• UDI-Device Identifier: 10886982226709
• UDI-Public: (01)10886982226709(17)UNK(10)4062142
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/12/2018

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: 456.304S
• Device Catalogue Number: 456.304S
• Device Lot Number: 4062142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/06/2018
• 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