MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM; PLATE, FIXATION, BONE

Model Number	02.107.304
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hwc.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.(b)(4).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) 2019, the patient underwent a hardware removal due to left elbow monteggia fracture dislocation with ulnar nonunion, status post bone grafting with now painful deep hardware, possible delayed union, as well as ulnar nerve compression.On (b)(6) 2017, the patient underwent a surgery and was diagnosed with nonunion left proximal ulna status post open reduction internal fixation monteggia fracture subluxation and was implanted with a synthes plate and screws.Concomitant devices reported: 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/28mm (part number 02.118.528, lot unknown, quantity 1), 2.7mm va lckng screw slf-tpng with t8 stardrive recess 24mm (part number 02.211.024, lot unknown, quantity 1), 2.7mm va lck screw slf-tap (part number 02.211.036, lot unknown, quantity 1), 2.7mm va lckng screw slf-tpng with t8 stardrive recess 40mm (part number 02.211.040, lot unknown, quantity 1).This report involves one (1) 2.7mm/3.5mm va-lcp olecranon pl 4h/lt/116mm.This is report 1 of 5 for (b)(4).This product (b)(4), captures the remaining five (5) out of fifteen (15) devices.(b)(4) captures the first ten (10) devices of the third revision.(b)(4) captures the first revision, removal of radial head and stem, that involves two (2) devices.(b)(4) captures the second revision, open reduction internal fixation with plates and screws and compression, that involves ten (10) out of eighteen (18) devices, and (b)(4) captures the remaining eight (8) out of eighteen (18) devices.

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM
• 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: 10441862
• Report Number: 2939274-2020-03735
• Device Sequence Number: 3974917
• Product Code: HRS
• UDI-Device Identifier: 10886982029355
• UDI-Public: (01)10886982029355
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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: 02.107.304
• Device Catalogue Number: 02.107.304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 101