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
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7603128
• Report Number: 2939274-2018-52507
• Device Sequence Number: 10821214
• Product Code: HRS
• UDI-Device Identifier: 10886982029355
• UDI-Public: (01)10886982029355
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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
• Operator of Device: Health Professional
• Device Model Number: 02.107.304
• Device Catalogue Number: 02.107.304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1