MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VAL T-PLATE 3 HOLES HD-7 HOLES SHAFT; PLATE, FIXATION, BONE

Model Number 02.130.252

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Case id reported as #(b)(6).Additional procode: hwc.Device has not been explanted.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.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Code (b)(4) used to capture surgical delay of three (3) minutes.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, the distal right hole of the variable angle locking (val) t-plate did not lock with a cortex screw.The cortex screw was already full seated on the plate and the surgeon spun the screw in circles without the locking mechanism engaging.The cortex screw was pulled out and was reused on another hole and was able to lock successfully.As per consultant, there was nothing wrong with the screw.The surgeon re-drilled the path to try the cortex screw again and it did not lock upon the second time.A proper drill guide was also used during the procedure.Procedure was completed successfully with a surgical delay of three (3) minutes.Patient's status is stable.Concomitant devices reported: 1.5mm cortex screw self-tapping with t4 stardrive recess 12mm (part: 02.214.112, lot: unknown, quantity: 1), 1.1mm va locking double drill guide/freehand/1.5mm val plate (part: 03.130.221, lot: unknown, quantity: 1) this report is for a 1.5mm val t-plate 3 holes hd-7 holes shaft.This is report 1of 1 for (b)(4).

• Brand Name: 1.5MM VAL T-PLATE 3 HOLES HD-7 HOLES SHAFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7660375
• MDR Text Key: 113195448
• Report Number: 2939274-2018-52714
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982044792
• UDI-Public: (01)10886982044792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.130.252
• Device Catalogue Number: 02.130.252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/03/2018
• 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 Age: 40 YR