MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.483S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Year of event reported as 2018; however exact date of postoperative malunion development is unknown.Additional device product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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) 2018 a patient underwent hardware removal of a trochanteric fixation (tfn) intramedullary nail and a helical blade due to malunion.The surgeon determined that the malunion was not a result of hardware failure.The original procedure was done on (b)(6) 2018.During revision surgery, the surgeon re-reduced the fracture and implanted a new intramedullary nail.There are no reports of surgical delay.The procedure and patient outcome is unknown.This report is for one (1) 12mm/130 degree ti cannulated troch fixation nail 420mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TROCH FIXATION NAIL 420MM/LEFT-STER
• 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: 7956231
• Report Number: 2939274-2018-54304
• Device Sequence Number: 19157911
• Product Code: HSB
• UDI-Device Identifier: 10886982228437
• UDI-Public: (01)10886982228437
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 456.483S
• Device Catalogue Number: 456.483S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention