MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM; PLATE, FIXATION, BONE

Model Number 02.107.304

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hwc.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 the patient underwent open reduction internal fixation of olecranon and radial head, and olecranon plate implantation on (b)(6) 2018.The 4 hole 2.7/3.5 va olecranon plate was implanted and the two locking screws holes were left empty.During the procedure two of the locking holes in the plate did not allow the (2) unknown locking screws to engage and would not lockdown into the plate, and with pressure used to try and insert the screw, the holes began to strip the threads of the screw.It was noted that unknown cortex screw and unknown locking screw were used to attached the plate.There was a five (5) minute surgical delay reported.The procedure was successfully completed.Patient outcome was unknown.Concomitant device reported: cortex screw (part 202.Xxx, lot unknown, quantity unknown); locking screw (part 02.211.Xxx, lot unknown, quantity unknown) this is report 1 of 3 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM
• 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7603128
• MDR Text Key: 111154241
• Report Number: 2939274-2018-52507
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982029355
• UDI-Public: (01)10886982029355
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120070
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.107.304
• Device Catalogue Number: 02.107.304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1