MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.315S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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 on (b)(6) 2018, the patient underwent removal of a trochanteric fixation nail (tfn) due to a fracture below the short nail.The surgeon removed the nail and replaced it with a long proximal femoral nailing system (tfna).Original surgery was done on (b)(6) 2018.The surgeon missed with the distal locking screw for the nail in the original surgery.There was no surgical delay.Patient outcome was stable.This complaint captures the post-operative fracture.The surgeon missing with the distal locking screw in the original procedure is being captured under related complaint (b)(4).This report is for a tfn nail.This is report 1 of 3 for (b)(4).

• Brand Name: 10MM/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: 7926996
• Report Number: 2939274-2018-54078
• Device Sequence Number: 16622799
• Product Code: HSB
• UDI-Device Identifier: 10886982226907
• UDI-Public: (01)10886982226907
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2018

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: 456.315S
• Device Catalogue Number: 456.315S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2018
• Initial Report FDA Received Date: 10/02/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 79