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

Model Number	02.107.202
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2020
Type of Reportable Event	Malfunction
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
It was reported that on (b)(6) 2020, a procedure open reduction internal fixation distal humerus and olecranon was performed.A right-side olecranon plate may have been implanted into a left elbow.When restocking implants used in the case a few days later it was noticed that the right side plate was missing even though we had billed for, and re-ordered a plate for the left side.The surgery was on the left arm, but there was a right side plate missing.The surgeon commented that the x-ray confirmed a right-sided plate was indeed implanted on the left olecranon.The surgeon was not planning any further treatments, saying the plate fit the bone well and is in a satisfactory position.The procedure was successfully completed.There were no fragments generated and no surgical delay reported.This report is for one (1) 2.7mm/3.5mm va-lcp olecranon pl 2h/rt/90mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/RT/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: 11229326
• Report Number: 2939274-2021-00466
• Device Sequence Number: 3512218
• Product Code: HRS
• UDI-Device Identifier: 10886982029263
• UDI-Public: (01)10886982029263
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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: 02.107.202
• Device Catalogue Number: 02.107.202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1