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

Model Number 475.940

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

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 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
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7400778
• MDR Text Key: 104532764
• Report Number: 2939274-2018-51479
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886982234612
• UDI-Public: (01)10886982234612(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 475.940
• Device Catalogue Number: 475.940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 77