MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Part number: 456.305, lot number: 5680170, part manufacturing date: 31 december 2007, manufacturing site: (b)(4), part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 5680170 of ti helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformance noted.This 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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 on (b)(6) 2020 the patient underwent the removal of bilateral trochanteric fixation nail advanced (tfna) nails in both right and left legs due to non-union and infection.For the right leg, one (1) titanium cannulated trochanteric fixation nail, one (1) helical blade, and two (2) unknown 5.0mm screws were removed.For the left leg, one (1) titanium cannulated trochanteric fixation nail, one (1) end cap, one (1) helical blade, and one (1) unknown 5.0mm screw were removed.The right limb incurred a secondary fracture of the proximal femur upon the nail removal.This fracture will be addressed at a later date.There was no surgical delay.The devices were removed and the procedure was successfully completed.This report is for one (1) 11.0mm ti helical blade 100mm.This is report 6 of 8 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 100MM
• 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: 9662133
• Report Number: 2939274-2020-00621
• Device Sequence Number: 19701625
• Product Code: HSB
• UDI-Device Identifier: 10886982226716
• UDI-Public: (01)10886982226716
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 456.305
• Device Catalogue Number: 456.305
• Device Lot Number: 5680170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1