MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM; PLATE, FIXATION, BONE

Model Number	02.107.302
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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.(b)(4).The locking screw would not lock into the plate, causing surgeon to use a cortical screw instead.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 on (b)(6) 2018, the variable angle (va) locking screw would not lock into one of the holes on the va locking compression plate (lcp) olecranon plate.The plate was still implanted and the surgeon implant an unknown cortical screw in that hole instead.The patient outcome was not affected but there was a 10 minute delay in the case.Procedure outcome was unknown.This report is for one (1) 2.7mm/3.5mm va lcp olecranon plate.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM
• 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: 8198105
• Report Number: 2939274-2018-55592
• Device Sequence Number: 16586922
• Product Code: HRS
• UDI-Device Identifier: 10886982029331
• UDI-Public: (01)10886982029331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2018

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
• Operator of Device: Health Professional
• Device Model Number: 02.107.302
• Device Catalogue Number: 02.107.302
• Device Lot Number: 660782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2018
• Initial Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention