MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 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	Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight is unknown.Date of post-operative infection development is unknown.Implanted approximately 2 years prior to removal surgery; exact date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed.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 was implanted with an unknown synthes trochanteric fixation nail (tfn) and a synthes 11.0mm titanium (ti) helical blade 90mm length on an unknown date approximately 2 years ago to treat an unknown fracture.On an unknown date postoperatively, the patient presented with pain.The patient was returned to the operating room on (b)(6) 2017, where an active infection was identified and where the implanted devices were removed intact and without difficulty.The procedure was completed successfully and the patient was reported in stable condition.This report is for one (1) 11.0mm ti helical blade 90mm.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 90MM
• 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: 7189421
• Report Number: 2939274-2018-50257
• Device Sequence Number: 158482
• Product Code: HSB
• UDI-Device Identifier: 10886982226679
• UDI-Public: (01)10886982226679(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/15/2018
• 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
• Patient Age: 72 YR