MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI CANNULATED FEMORAL NAIL 420MM-STERILE; PIN,FIXATION,SMOOTH

Model Number	474.242S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight not available for reporting.Date patient pain began is not known.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) 12mm cannulated femoral nail.This is report 1 of 8 for (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: manufacturing location: (b)(4), manufacturing date: 22-dec-2009 , expiration date: 31-nov-2018.Part #: 474.242s, lot#: 6283075 (sterile) - 12mm ti cannulated femoral nail 420mm - sterile.Quantity 6.Component parts reviewed: 474.242, 12mm ti cannulated femoral bp 20.Lot: 4978927.Raw material for titanium has been reviewed and it meet specification.No non-conformances (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Scn, ¿sterility documentation was reviewed and determined to be conforming.¿ no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• Brand Name: 12MM TI CANNULATED FEMORAL NAIL 420MM-STERILE
• 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: 7275429
• Report Number: 2939274-2018-50647
• Device Sequence Number: 165048
• Product Code: HTY
• UDI-Device Identifier: 10886982233615
• UDI-Public: (01)10886982233615(17)EXPIRATIONUNKNOWN(10)6283075
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K954856
• 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,Followup
• 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 Expiration Date: 11/30/2018
• Device Model Number: 474.242S
• Device Catalogue Number: 474.242S
• Device Lot Number: 6283075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/26/2018
• 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