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	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) 2.7mm/3.5mm va-lcp proximal olecranon pl 2h/lt/73mm.This is report 1 of 13 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part number: 02.107.102-us, lot number: 99p0881, part manufacture date: 05-apr-2021, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 2.7mm/3.5mm va-lcp proximal product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.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: 2.7MM/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
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14142023
• Report Number: 2939274-2022-01351
• Device Sequence Number: 19893025
• Product Code: HRS
• UDI-Device Identifier: 10886982029249
• UDI-Public: (01)10886982029249
• 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 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: 02.107.102
• Device Catalogue Number: 02.107.102
• Device Lot Number: 99P0881
• 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
• Date Device Manufactured: 04/05/2021
• 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: 2.0 VAL COND PL 2 HOLES HD-6 HOLES SFT; 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