MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.9MM TI LOCKING BOLT 42MM; PIN,FIXATION,SMOOTH

Model Number	459.42
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight not available for reporting.Date patient pain began is not known.(b)(4).Date of implant reported as (b)(6) 2010, exact date is unknown.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 patient sustained a broken left femur in a motor vehicle accident in (b)(6) 2010.Patient was implanted with the trochanteric nail system on unknown date.Patient reports pain in the left leg.Patient has had follow up visits to the doctor but does not know if explantation of the devices is planned.X-rays taken on unknown date indicate the bone is growing over the nail.This report is for one (1) 4.9mm locking bolt.This is report 2 of 8 for (b)(4).

• Brand Name: 4.9MM TI LOCKING BOLT 42MM
• Common Device Name: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7275453
• Report Number: 2939274-2018-50649
• Device Sequence Number: 143461
• Product Code: HTY
• UDI-Device Identifier: 10886982231499
• UDI-Public: (01)10886982231499(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K970733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2018

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: 459.42
• Device Catalogue Number: 459.42
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/15/2018
• 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: 61 YR