MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM VAL CONDYLAR PLATE 2 HOLES HD-6 HOLES SHAFT; PLATE, FIXATION, BONE

Model Number	02.130.355
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent hardware removal procedure due to discomfort.The devices explanted were one (1) 2.7mm/3.5mm va-lcp proximal olecranon plate, one (1) 2.0mm val condylar plate, two (2) 3.5mm cortex screws, four (4) 2.7mm va locking screws and five (5) 2.0mm va locking screws.All implants were removed intact and bone had successfully healed.This report is for one (1) 2.0mm val condylar plate 2 holes hd-6 holes shaft.This is report 2 of 13 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 2.0MM VAL CONDYLAR PLATE 2 HOLES HD-6 HOLES SHAFT
• 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): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14142061
• Report Number: 2939274-2022-01352
• Device Sequence Number: 14449678
• Product Code: HRS
• UDI-Device Identifier: 10886982045416
• UDI-Public: (01)10886982045416
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 02.130.355
• Device Catalogue Number: 02.130.355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/19/2022
• 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 PROXIMAL OLEC PL 2H/LT/73.; UNK - SCREWS: 2.7 MM VA LOCKING.; UNK - SCREWS: 2.7 MM VA LOCKING.; UNK - SCREWS: 2.7 MM VA LOCKING.; UNK - SCREWS: 2.7 MM VA LOCKING.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.; UNK - SCREWS: LOCKING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 52 KG