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

Model Number	02.107.202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2015 the patient had a displaced comminuted acute olecranon fracture right elbow which was fixed with a synthes olecranon locking plate, 5 screws in the shaft with bicortical fixation, and 4 locking unicortal screws in the proximal segment.On or about (b)(6) 2016, synthes announced a recall of the system due to the discovery that the system was defective and could cause the radial stem to loosen post-operatively at the stem bone interface.On (b)(6) 2017, the patient underwent revision due to pain, right elbow retained hardware, osteolysis secondary to loose implant - radial head, and failed radial head arthroplasty.Operative findings discovered hyperthropy and synovitis, chondromalacis of capitellum grade ii, grade ii with peripheral spur.The olecranon fracture healed without any loosening or evidence of any osteolysis around olecranon plate and screws.This is report 1 of 12 for (b)(4).
Additional Manufacturer Narrative
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/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.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
Update: on (b)(6), 2015 patient had a displaced comminuted acute olecranon fracture right elbow and neck fracture.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5.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.

• Brand Name: 2.7/3.5 VA-LCP OLECRANON PL 2H/RT/90
• Common Device Name: 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14085287
• Report Number: 2939274-2022-01257
• Device Sequence Number: 5276582
• Product Code: HRS
• UDI-Device Identifier: 10886982029263
• UDI-Public: (01)10886982029263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.107.202
• Device Catalogue Number: 02.107.202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7/3.5 VA-LCP OLECRANON PL 2H/RT/90; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 2.7MM VA LCK SCREW SLF-TAP; 22 COCR RADIAL HEAD STD HEIGHT/12.5-SILE; 7MM TI STRAIGHT RADIAL STEM 26MM-STERILE; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic