MAUDE Adverse Event Report: 1302 WRIGHTS LANE EAST; APPLIANCE, FIXATION, NAIL

Device Problems Sticking (1597); Fitting Problem (2183); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 02/19/2016

Event Type  Injury  

Manufacturer Narrative

510(k): report is for one (1) unknown lag screw.(b)(4).Unknown when device was implanted.(b)(4).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 Description

It was reported during hardware removal on (b)(6) 2016, two (2) of the four (4) cortical screws broke and the screw shafts were left implanted in the patient.Additionally, the plate would not disengage from the lag screw and were found to be welded together.Because the devices were welded together, there was a (15) minute surgical delay to remove the devices; they were removed as one unit.X-rays were taken intraoperatively during revision surgery and additional x-rays were taken to aid in removal of the welded devices.The surgeon held onto the plate and turned the screw counterclockwise to enable removal.Patient status was reported as "ok." procedure was completed successfully.Com-(b)(4) is to report the intra-operative complications that reportedly occurred during the revision surgery.The patient undergoing device removal as a result of hip pain is reported under com-(b)(4).This report is for one (1) unknown lag screw.This is report 2 of 3 for com-(b)(4).

• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): 1302 WRIGHTS LANE EAST; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5483624
• MDR Text Key: 39783357
• Report Number: 2520274-2016-11498
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 75