MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI ELASTIC NAIL 440MM; PIN,FIXATION,SMOOTH

Model Number	475.940
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: date of device migration is not known.Date of implant reported only as 2011.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.(b)(4).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 4.0mm titanium elastic naill due to the device extruding into the knee joint.The patient was originally implanted with two (2) elastic nails on an unknown date sometime around the year of 2011.Following that original procedure, the patient was told to have both of the devices removed for unknown reasons.During the (b)(6) 2018 procedure, one (1) of the two (2) elastic nails were removed (the one extruding into the knee) and an incision and drainage (i&d) was performed on the knee joint.The surgery was successfully completed with no reported surgical delay.The patient was reported to be okay following the procedure.Concomitant device reported: elastic nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) 4.0mm titanium elastic nail 440mm.(b)(4).

• Brand Name: 4.0MM TI ELASTIC NAIL 440MM
• 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: 7400778
• Report Number: 2939274-2018-51479
• Device Sequence Number: 19160990
• Product Code: HTY
• UDI-Device Identifier: 10886982234612
• UDI-Public: (01)10886982234612(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K971783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 475.940
• Device Catalogue Number: 475.940
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/05/2018
• 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: 22 YR
• Patient Weight: 77