MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/LT/73MM; PLATE, FIXATION, BONE

Model Number	02.107.102
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: picture review from medical safety officer: the olecranon has pulled away completely from the proximal end of the plate and six screws as evidenced in the radiograph.I can't confirm the infection or that the implants were removed.For detailed information see document ¿picture review from medical safety officer - complaint (b)(4) - usa¿, attached to pc level.Product was not returned therefore no further investigation possible.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 (information or/and material), 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 an unknown date, the patient underwent removal of variable angle locking compression plate (va-lcp) proximal olecranon plate and unknown screws due to aseptic loosening and infection.The surgeon originally tried using a long cannulated screw through the proximal ulna to fixate the proximal piece.That didn¿t hold well enough and add the olecranon plate.There was a patient consequence.(b)(4) captured the 2nd revision where in all the devices were removed due aseptic loosening and infection, (b)(4) captures the 1st revision where in additional implant were implanted the variable angle locking compression plate (va-lcp) proximal olecranon plate since on the original surgery the unknown cannulated screw that used fixate the proximal piece did not hold well enough.This report is for one 2.7mm/3.5mm va-lcp proximal olecranon pl 2h/lt/73mm.This complaint involves ten (10) devices.This report is 1 of 10 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/LT/73MM
• 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: 10019107
• Report Number: 2939274-2020-02194
• Device Sequence Number: 2967912
• Product Code: HRS
• UDI-Device Identifier: 10886982029249
• UDI-Public: (01)10886982029249
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K120070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2020

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: 02.107.102
• Device Catalogue Number: 02.107.102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention