MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM METAPH SCRW S/TAP 18MM; PLATE,FIXATION,BONE

Model Number 02.118.518

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Muscular Rigidity (1968); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional product code hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 Description

It was reported that on (b)(6) 2019, the patient underwent a right radial head revision reconstruction, removal of hardware of the olecranon as well as the radial head, lysis of adhesion and debridement and was implanted with a non-synthes device due to a right elbow radial head replacement failure, symptomatic hardware with stiffness and increasing pain.On (b)(6) 2015, the patient has presented discomfort with pain over the right elbow which radiates to the right elbow.The patient fell down on her elbow and sustained a fracture dislocation.She also had nerve symptoms mostly in the ulnar distribution.On (b)(6) 2015, the patient underwent a right olecranon open reduction internal fixation, radial head resection with radial head replacement and open reduction of radial head and was implanted with depuy synthes 20mm diameter head and a 4 hole long right olecranon plate.The patient was diagnosed with right elbow fracture-dislocation, radial head olecranon comminuted fracture and ulnar neurapraxia.On (b)(6) 2016, ct right upper extremity shows plate and screw fixation of the proximal ulna.Comminuted intra-articular fracture now with bridging callus formation.Bridging callus formation is now seen across nondisplaced coronoid process fracture.On (b)(6) 2016, ct shows atrophic nonunion of proximal ulna fracture, on (b)(6) 2017, ct of the upper right extremity shows stable mild loosening of the radial head prosthesis and stable heterotopic ossification of posterior lateral to the radial head prosthesis.Radial head prosthesis with 2 mm zone of lucency surrounding the stem unchanged and suspicious for loosening.On (b)(6) 2019, the patient was diagnosed with a closed fracture of the right olecranon process with nonunion.Also has persistent neck pain and stiffness.The patient presents with complaints of gradual onset.On (b)(6) 2020, ct reveals posterior dislocation of the radial head prosthesis and osteoarthritis.On (b)(6) 2020, the patient underwent a right ulnar nerve decompression, left elbow lysis of adhesion, right elbow removal of hardware of radial head.This complaint involves nineteen (19) devices.This report involves one (1) 2.7mm metaph scrw s/tap 18mm.This is report 8 of 9 (b)(4).

• Brand Name: 2.7MM METAPH SCRW S/TAP 18MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11252453
• MDR Text Key: 229594467
• Report Number: 2939274-2021-00573
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982039248
• UDI-Public: (01)10886982039248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.118.518
• Device Catalogue Number: 02.118.518
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 100