MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.318S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Investigation summary: 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.
Event or Problem Description
It was reported that patient underwent a removal of all trochanteric fixation nail (tfn) hardware on (b)(6) 2018 due to pain in the hip area.On an unknown date, the patient underwent an open reduction of the right hip and was originally implanted with a (tfn) short nail.All hardware were removed successfully with no complications or extended time needed.The surgeon implanted a tension band plate after hardware removal to supply additional strength to the right hip.Hardware was all intact.Patient outcome unknown.This complaint is for one (1) 11mm/130 deg ti cann troch fixation nail 170mm-sterile this complaint involves three (3) devices.This report is 1 of 3 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
• 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: 8113186
• Report Number: 2939274-2018-55136
• Device Sequence Number: 1721864
• Product Code: HSB
• UDI-Device Identifier: 10886982226938
• UDI-Public: (01)10886982226938
• Combination Product (Y/N): N
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 456.318S
• Device Catalogue Number: 456.318S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/28/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR